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Trial record 2 of 16 for:    RTH258

Efficacy and Safety of RTH258 Versus Aflibercept - Study 1 (HAWK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02307682
Recruitment Status : Completed
First Posted : December 4, 2014
Results First Posted : October 31, 2019
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Neovascular Age-Related Macular Degeneration
Choroidal Neovascularization
Interventions Drug: Brolucizumab ophthalmic solution
Drug: Aflibercept ophthalmic solution
Enrollment 1775
Recruitment Details Subjects were recruited from investigative sites located in Argentina, Australia, Canada, Colombia, Israel, Japan, Mexico, New Zealand, Panama, Puerto Rico, and USA.
Pre-assignment Details Of the 1775 subjects enrolled in the study, 693 were exited prior to randomization as screen failures. This reporting group includes all randomized subjects.
Arm/Group Title Brolucizumab 3 mg Brolucizumab 6 mg Aflibercept 2 mg
Hide Arm/Group Description Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
Period Title: Overall Study
Started [1] 360 361 361
Randomized and Treated 358 360 360
Completed 310 304 297
Not Completed 50 57 64
Reason Not Completed
Adverse Event             9             8             12
Lack of Efficacy             1             0             1
Physician Decision             2             2             8
Progressive Disease             1             0             0
Withdrawal by Subject             26             34             23
Death             9             7             12
Lost to Follow-up             1             5             6
Protocol Deviation             0             0             2
Other             1             1             0
[1]
All randomized subjects
Arm/Group Title Brolucizumab 3 mg Brolucizumab 6 mg Aflibercept 2 mg Total
Hide Arm/Group Description Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit Total of all reporting groups
Overall Number of Baseline Participants 358 360 360 1078
Hide Baseline Analysis Population Description
This analysis population includes all randomized subjects who received at least 1 IVT injection of study treatment (Full Analysis Set).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 358 participants 360 participants 360 participants 1078 participants
76.7  (8.28) 76.7  (8.95) 76.2  (8.80) 76.5  (8.68)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 358 participants 360 participants 360 participants 1078 participants
Less than 50 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
50-64 years
31
   8.7%
35
   9.7%
37
  10.3%
103
   9.6%
65-74 years
103
  28.8%
103
  28.6%
112
  31.1%
318
  29.5%
75-84 years
162
  45.3%
155
  43.1%
148
  41.1%
465
  43.1%
85 years and greater
62
  17.3%
67
  18.6%
63
  17.5%
192
  17.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 358 participants 360 participants 360 participants 1078 participants
Female
210
  58.7%
205
  56.9%
194
  53.9%
609
  56.5%
Male
148
  41.3%
155
  43.1%
166
  46.1%
469
  43.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 358 participants 360 participants 360 participants 1078 participants
Hispanic or Latino
32
   8.9%
29
   8.1%
40
  11.1%
101
   9.4%
Not Hispanic or Latino
323
  90.2%
329
  91.4%
319
  88.6%
971
  90.1%
Unknown or Not Reported
3
   0.8%
2
   0.6%
1
   0.3%
6
   0.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 358 participants 360 participants 360 participants 1078 participants
American Indian or Alaska Native
1
   0.3%
1
   0.3%
1
   0.3%
3
   0.3%
Asian
44
  12.3%
61
  16.9%
53
  14.7%
158
  14.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   0.3%
1
   0.3%
1
   0.3%
3
   0.3%
White
302
  84.4%
285
  79.2%
287
  79.7%
874
  81.1%
More than one race
1
   0.3%
3
   0.8%
1
   0.3%
5
   0.5%
Unknown or Not Reported
9
   2.5%
9
   2.5%
17
   4.7%
35
   3.2%
Best Corrected Visual Acuity (BCVA) (letters read)   [1] 
Mean (Standard Deviation)
Unit of measure:  Letters
Number Analyzed 358 participants 360 participants 360 participants 1078 participants
61.0  (13.57) 60.8  (13.66) 60.0  (13.92) 60.6  (13.71)
[1]
Measure Description: BCVA (with spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.
1.Primary Outcome
Title Change From Baseline in Best Corrected Visual Acuity (BCVA) (Letters Read) at Week 48 - Study Eye
Hide Description BCVA (with spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) - Last Observation Carried Forward (LOCF)
Arm/Group Title Brolucizumab 3 mg Brolucizumab 6 mg Aflibercept 2 mg
Hide Arm/Group Description:
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
Overall Number of Participants Analyzed 358 360 360
Mean (Standard Deviation)
Unit of Measure: letters
5.9  (13.49) 6.4  (14.40) 7.0  (13.16)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The non-inferiority margin was 4 letters.
Statistical Test of Hypothesis P-Value 0.0003
Comments 1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-2.5 to 1.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.98
Estimation Comments Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The non-inferiority margin was 4 letters.
Statistical Test of Hypothesis P-Value <0.0001
Comments 1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-2.1 to 1.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.00
Estimation Comments Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
2.Secondary Outcome
Title Average Change From Baseline in BCVA (Letters Read) Over the Period Week 36 Through Week 48 - Study Eye
Hide Description BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. For each subject, this endpoint was defined as the average of the changes from baseline to Weeks 36, 40, 44, and 48. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.
Time Frame Baseline, Weeks 36, 40, 44, 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS - LOCF
Arm/Group Title Brolucizumab 3 mg Brolucizumab 6 mg Aflibercept 2 mg
Hide Arm/Group Description:
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
Overall Number of Participants Analyzed 358 360 360
Mean (Standard Deviation)
Unit of Measure: letters
6.0  (13.37) 6.5  (13.85) 6.9  (12.61)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The non-inferiority margin was 4 letters.
Statistical Test of Hypothesis P-Value 0.0001
Comments 1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-2.4 to 1.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.95
Estimation Comments Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The non-inferiority margin was 4 letters.
Statistical Test of Hypothesis P-Value <0.0001
Comments 1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-1.9 to 1.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.96
Estimation Comments Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
3.Secondary Outcome
Title Proportion of Subjects With Positive q12 (Every 12 Weeks) Treatment Status at Week 48
Hide Description Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44) to identify q8w (one injection every 8 weeks) need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. No hypothesis testing was performed. This outcome measure was pre-specified for brolucizumab 3mg and 6 mg arms only.
Time Frame Weeks 16, 20, 28, 32, 40, 44, 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS - efficacy/safety approach
Arm/Group Title Brolucizumab 3 mg Brolucizumab 6 mg
Hide Arm/Group Description:
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
Overall Number of Participants Analyzed 358 360
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of subjects
0.4939
(0.4393 to 0.5461)
0.5563
(0.5016 to 0.6075)
4.Secondary Outcome
Title Proportion of Subjects With Positive q12 Treatment Status at Week 48 Within the Subjects With no q8 (Every 8 Weeks) Treatment Need During the First q12 Cycle (Week 16, Week 20)
Hide Description Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A DAA was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% CIs were derived from the LOGLOG transformation. No hypothesis testing was performed. This outcome measure was pre-specified for the brolucizumab 3 mg and 6 mg arms only.
Time Frame Weeks 16, 20, 28, 32, 40, 44, 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS - efficacy/safety approach
Arm/Group Title Brolucizumab 3 mg Brolucizumab 6 mg
Hide Arm/Group Description:
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
Overall Number of Participants Analyzed 208 222
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of subjects
0.8085
(0.7454 to 0.8574)
0.8539
(0.7987 to 0.8950)
5.Secondary Outcome
Title Proportion of Subjects With Positive q12 Treatment Status up to Week 96
Hide Description Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A DAA was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% CIs were derived from the LOGLOG transformation. No hypothesis testing was performed. This outcome measure was pre-specified for the brolucizumab 3 mg and 6 mg arms only.
Time Frame Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92, 96
Hide Outcome Measure Data
Hide Analysis Population Description
FAS - efficacy/safety approach
Arm/Group Title Brolucizumab 3 mg Brolucizumab 6 mg
Hide Arm/Group Description:
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
Overall Number of Participants Analyzed 358 360
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of subjects
0.3973
(0.3427 to 0.4514)
0.4537
(0.3984 to 0.5072)
6.Secondary Outcome
Title Proportion of Subjects With Positive q12 Treatment Status at Week 96 Within the Subjects With no q8 Treatment Need During the Initial q12 Cycle (Week 16, Week 20)
Hide Description Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A DAA was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% CIs were derived from the LOGLOG transformation. No hypothesis testing was performed. This outcome measure was pre-specified for the brolucizumab 3 mg and 6 mg arms only.
Time Frame Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92, 96
Hide Outcome Measure Data
Hide Analysis Population Description
FAS - efficacy/safety approach
Arm/Group Title Brolucizumab 3 mg Brolucizumab 6 mg
Hide Arm/Group Description:
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
Overall Number of Participants Analyzed 208 222
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of subjects
0.6504
(0.5749 to 0.7159)
0.6963
(0.6270 to 0.7554)
7.Secondary Outcome
Title Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Hide Description BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.
Time Frame Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96
Hide Outcome Measure Data
Hide Analysis Population Description
FAS - LOCF
Arm/Group Title Brolucizumab 3 mg Brolucizumab 6 mg Aflibercept 2 mg
Hide Arm/Group Description:
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
Overall Number of Participants Analyzed 358 360 360
Mean (Standard Deviation)
Unit of Measure: letters
Change from baseline at Week 4 3.7  (8.36) 3.8  (9.77) 4.2  (7.93)
Change from baseline at Week 8 5.7  (8.83) 5.5  (10.71) 6.1  (9.48)
Change from baseline at Week 12 5.7  (10.19) 6.0  (11.71) 6.3  (10.41)
Change from baseline at Week 16 5.7  (11.44) 6.3  (11.65) 6.1  (10.89)
Change from baseline at Week 20 6.2  (11.40) 6.2  (12.30) 7.1  (11.25)
Change from baseline at Week 24 6.1  (11.95) 6.4  (12.50) 6.8  (11.72)
Change from baseline at Week 28 6.2  (12.67) 6.7  (13.23) 6.7  (12.30)
Change from baseline at Week 32 5.6  (13.42) 6.8  (13.41) 6.6  (12.43)
Change from baseline at Week 36 5.6  (13.45) 6.5  (13.74) 7.1  (12.46)
Change from baseline at Week 40 6.2  (13.96) 6.6  (14.55) 6.9  (12.96)
Change from baseline at Week 44 6.2  (14.05) 6.6  (14.01) 6.7  (13.37)
Change from baseline at Week 48 5.9  (13.49) 6.4  (14.40) 7.0  (13.16)
Change from baseline at Week 52 6.2  (14.00) 6.2  (14.58) 6.8  (14.10)
Change from baseline at Week 56 6.2  (14.08) 6.1  (14.88) 7.1  (13.31)
Change from baseline at Week 60 6.2  (14.26) 6.2  (14.72) 6.7  (13.96)
Change from baseline at Week 64 5.9  (14.67) 6.0  (15.16) 6.6  (13.75)
Change from baseline at Week 68 6.0  (14.60) 5.9  (15.10) 6.5  (13.95)
Change from baseline at Week 72 6.0  (14.95) 5.6  (14.80) 6.2  (14.50)
Change from baseline at Week 76 6.2  (14.91) 5.9  (15.09) 6.3  (14.21)
Change from baseline at Week 80 6.1  (14.83) 6.1  (15.33) 5.8  (14.42)
Change from baseline at Week 84 5.8  (15.01) 5.5  (14.94) 5.6  (14.36)
Change from baseline at Week 88 5.8  (15.43) 5.7  (15.45) 5.8  (14.67)
Change from baseline at Week 92 5.8  (15.48) 5.8  (15.21) 5.9  (14.64)
Change from baseline at Week 96 5.4  (15.86) 5.6  (15.62) 5.6  (14.78)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 4
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-1.4 to 0.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.59
Estimation Comments Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-1.4 to 1.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.64
Estimation Comments Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 8
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-1.4 to 1.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.67
Estimation Comments Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 8
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-1.7 to 1.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.73
Estimation Comments Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 12
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-1.8 to 1.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.76
Estimation Comments Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 12
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-1.5 to 1.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.80
Estimation Comments Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 16
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-1.8 to 1.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.82
Estimation Comments Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 16
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
-1.1 to 2.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.82
Estimation Comments Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 20
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-2.2 to 1.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.83
Estimation Comments Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 20
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-2.2 to 1.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.86
Estimation Comments Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 24
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-2.1 to 1.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.87
Estimation Comments Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 24
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-1.9 to 1.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.88
Estimation Comments Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 28
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-1.9 to 1.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.92
Estimation Comments Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 28
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-1.4 to 2.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.92
Estimation Comments Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 32
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-2.4 to 1.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.94
Estimation Comments Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 32
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
-1.2 to 2.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.94
Estimation Comments Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 36
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-2.9 to 0.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.94
Estimation Comments Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 36
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-2.1 to 1.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.95
Estimation Comments Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 40
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-2.2 to 1.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.98
Estimation Comments Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 40
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-1.9 to 2.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.00
Estimation Comments Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 44
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-2.1 to 1.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.00
Estimation Comments Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 44
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-1.8 to 2.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.00
Estimation Comments Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 48
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-2.5 to 1.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.98
Estimation Comments Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 48
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-2.1 to 1.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.00
Estimation Comments Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 52
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-2.2 to 1.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.03
Estimation Comments Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 52
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-2.2 to 1.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.04
Estimation Comments Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 56
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-2.5 to 1.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.00
Estimation Comments Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)
Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 56
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-2.7 to 1.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.03
Estimation Comments Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 60
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-2.1 to 1.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.03
Estimation Comments Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)
Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 60
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-2.2 to 1.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.04
Estimation Comments Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 64
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-2.3 to 1.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.04
Estimation Comments Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)
Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 64
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-2.2 to 1.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.05
Estimation Comments Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 68
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-2.1 to 2.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.04
Estimation Comments Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)
Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 68
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-2.2 to 1.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.05
Estimation Comments Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 72
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-2.0 to 2.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.08
Estimation Comments Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)
Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 72
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-2.4 to 1.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.07
Estimation Comments Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 76
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-1.8 to 2.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.07
Estimation Comments Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)
Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 76
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-2.1 to 2.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.06
Estimation Comments Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 80
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
-1.5 to 2.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.07
Estimation Comments Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)
Hide Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 80
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-1.4 to 2.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.08
Estimation Comments Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
Hide Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 84
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
-1.5 to 2.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.08
Estimation Comments Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)
Hide Statistical Analysis 42
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 84
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-1.8 to 2.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.06
Estimation Comments Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
Hide Statistical Analysis 43
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 88
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-1.8 to 2.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.10
Estimation Comments Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)
Hide Statistical Analysis 44
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 88
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-1.9 to 2.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.10
Estimation Comments Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
Hide Statistical Analysis 45
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 92
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-1.9 to 2.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.10
Estimation Comments Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)
Hide Statistical Analysis 46
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 92
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-1.8 to 2.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.09
Estimation Comments Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
Hide Statistical Analysis 47
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 96
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-1.9 to 2.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.12
Estimation Comments Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)
Hide Statistical Analysis 48
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 96
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
-1.6 to 2.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.10
Estimation Comments Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
8.Secondary Outcome
Title Average Change From Baseline in BCVA (Letters Read) Over the Period Week 4 to Week 48/96 - Study Eye
Hide Description BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.
Time Frame Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96
Hide Outcome Measure Data
Hide Analysis Population Description
FAS - LOCF
Arm/Group Title Brolucizumab 3 mg Brolucizumab 6 mg Aflibercept 2 mg
Hide Arm/Group Description:
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
Overall Number of Participants Analyzed 358 360 360
Mean (Standard Deviation)
Unit of Measure: letters
Change from baseline over the period Week 4 to 48 5.7  (10.43) 6.2  (11.62) 6.5  (10.49)
Change from baseline over the period Week 4 to 96 5.8  (12.06) 6.0  (12.73) 6.4  (11.76)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 4 to Week 48
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-1.9 to 1.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.76
Estimation Comments Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 4 to Week 48
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-1.5 to 1.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.80
Estimation Comments Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 4 to Week 96
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-1.8 to 1.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.87
Estimation Comments Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 4 to Week 96
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-1.7 to 1.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.88
Estimation Comments Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
9.Secondary Outcome
Title Average Change From Baseline in BCVA (Letters Read) Over the Period Week 12 to Week 48/96 - Study Eye
Hide Description BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.
Time Frame Baseline, Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96
Hide Outcome Measure Data
Hide Analysis Population Description
FAS - LOCF
Arm/Group Title Brolucizumab 3 mg Brolucizumab 6 mg Aflibercept 2 mg
Hide Arm/Group Description:
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
Overall Number of Participants Analyzed 358 360 360
Mean (Standard Deviation)
Unit of Measure: letters
Change from baseline over the period Week 12 to 48 5.9  (11.45) 6.5  (12.28) 6.7  (11.27)
Change from baseline over the period Week 12 to 96 5.9  (12.76) 6.1  (13.21) 6.5  (12.28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 12 to Week 48
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-2.0 to 1.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.83
Estimation Comments Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 12 to Week 48
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-1.6 to 1.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.85
Estimation Comments Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 12 to Week 96
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-1.9 to 1.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.91
Estimation Comments Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 12 to Week 96
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-1.7 to 1.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.92
Estimation Comments Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
10.Secondary Outcome
Title Average Change From Baseline in BCVA (Letters Read) Over the Period Week 84 to Week 96 - Study Eye
Hide Description BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.
Time Frame Baseline, Weeks 84, 88, 92, 96
Hide Outcome Measure Data
Hide Analysis Population Description
FAS - LOCF
Arm/Group Title Brolucizumab 3 mg Brolucizumab 6 mg Aflibercept 2 mg
Hide Arm/Group Description:
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
Overall Number of Participants Analyzed 358 360 360
Mean (Standard Deviation)
Unit of Measure: letters
5.7  (15.15) 5.7  (15.05) 5.7  (14.29)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-1.7 to 2.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.08
Estimation Comments Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Treatment difference
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method ANOVA
Comments Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-1.7 to 2.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.06
Estimation Comments Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
11.Secondary Outcome
Title Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Hide Description BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
Time Frame Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96
Hide Outcome Measure Data
Hide Analysis Population Description
FAS - LOCF
Arm/Group Title Brolucizumab 3 mg Brolucizumab 6 mg Aflibercept 2 mg
Hide Arm/Group Description:
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
Overall Number of Participants Analyzed 358 360 360
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
Change from baseline at Week 4
9.2
(6.4 to 12.7)
10.8
(7.8 to 14.5)
9.7
(6.9 to 13.3)
Change from baseline at Week 8
15.9
(12.3 to 20.1)
19.2
(15.2 to 23.6)
15.6
(12.0 to 19.7)
Change from baseline at Week 12
20.1
(16.1 to 24.6)
24.4
(20.1 to 29.2)
20.3
(16.2 to 24.8)
Change from baseline at Week 16
22.6
(18.4 to 27.3)
22.5
(18.3 to 27.2)
20.8
(16.8 to 25.4)
Change from baseline at Week 20
22.6
(18.4 to 27.3)
25.8
(21.4 to 30.7)
22.8
(18.5 to 27.5)
Change from baseline at Week 24
23.2
(18.9 to 27.9)
28.3
(23.7 to 33.3)
21.9
(17.8 to 26.6)
Change from baseline at Week 28
27.4
(22.8 to 32.3)
28.1
(23.5 to 33.0)
25.8
(21.4 to 30.7)
Change from baseline at Week 32
25.4
(21.0 to 30.3)
31.9
(27.2 to 37.0)
25.0
(20.6 to 29.8)
Change from baseline at Week 36
24.9
(20.5 to 29.7)
31.7
(26.9 to 36.7)
24.7
(20.4 to 29.5)
Change from baseline at Week 40
27.1
(22.6 to 32.0)
33.6
(28.7 to 38.7)
26.4
(21.9 to 31.3)
Change from baseline at Week 44
27.7
(23.1 to 32.6)
34.2
(29.3 to 39.3)
27.5
(23.0 to 32.4)
Change from baseline at Week 48
24.9
(20.5 to 29.7)
33.1
(28.2 to 38.2)
25.8
(21.4 to 30.7)
Change from baseline at Week 52
29.9
(25.2 to 34.9)
31.7
(26.9 to 36.7)
28.1
(23.5 to 33.0)
Change from baseline at Week 56
29.9
(25.2 to 34.9)
31.7
(26.9 to 36.7)
29.7
(25.0 to 34.7)
Change from baseline at Week 60
27.7
(23.1 to 32.6)
32.5
(27.7 to 37.6)
28.6
(24.0 to 33.6)
Change from baseline at Week 64
30.7
(26.0 to 35.8)
32.5
(27.7 to 37.6)
27.8
(23.2 to 32.7)
Change from baseline at Week 68
29.9
(25.2 to 34.9)
32.5
(27.7 to 37.6)
28.1
(23.5 to 33.0)
Change from baseline at Week 72
30.4
(25.7 to 35.5)
31.4
(26.6 to 36.5)
27.5
(23.0 to 32.4)
Change from baseline at Week 76
33.8
(28.9 to 39.0)
32.5
(27.7 to 37.6)
28.6
(24.0 to 33.6)
Change from baseline at Week 80
28.5
(23.9 to 33.5)
35.6
(30.6 to 40.7)
27.8
(23.2 to 32.7)
Change from baseline at Week 84
29.3
(24.7 to 34.3)
30.0
(25.3 to 35.0)
26.7
(22.2 to 31.6)
Change from baseline at Week 88
31.0
(26.2 to 36.1)
34.7
(29.8 to 39.9)
27.8
(23.2 to 32.7)
Change from baseline at Week 92
28.8
(24.1 to 33.8)
32.8
(27.9 to 37.9)
28.1
(23.5 to 33.0)
Change from baseline at Week 96
32.1
(27.3 to 37.2)
33.6
(28.7 to 38.7)
27.5
(23.0 to 32.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 4
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-4.2 to 4.2
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 4
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 1.6
Confidence Interval (2-Sided) 95%
-2.8 to 5.8
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 8
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
-4.4 to 5.9
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 8
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 4.2
Confidence Interval (2-Sided) 95%
-1.2 to 10.0
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-5.9 to 5.9
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 4.9
Confidence Interval (2-Sided) 95%
-0.5 to 11.0
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 16
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
-3.7 to 8.0
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 16
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
-3.8 to 8.3
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 20
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-5.9 to 6.1
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 20
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 3.8
Confidence Interval (2-Sided) 95%
-2.4 to 9.9
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 24
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 1.9
Confidence Interval (2-Sided) 95%
-4.2 to 7.3
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 24
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 7.2
Confidence Interval (2-Sided) 95%
0.8 to 13.4
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 28
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
-4.3 to 8.5
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 28
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 3.2
Confidence Interval (2-Sided) 95%
-3.4 to 9.4
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 32
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
-5.0 to 7.2
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 32
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 7.9
Confidence Interval (2-Sided) 95%
1.5 to 14.4
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 36
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
-5.4 to 7.0
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 36
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 8.1
Confidence Interval (2-Sided) 95%
2.1 to 14.5
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 40
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
-4.4 to 8.1
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 40
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 8.3
Confidence Interval (2-Sided) 95%
2.0 to 15.1
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 44
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
-5.2 to 7.1
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 44
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 7.6
Confidence Interval (2-Sided) 95%
0.7 to 13.8
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 48
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-6.8 to 6.1
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 48
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 8.2
Confidence Interval (2-Sided) 95%
2.2 to 15.0
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 52
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 2.8
Confidence Interval (2-Sided) 95%
-3.9 to 9.2
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 52
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 4.8
Confidence Interval (2-Sided) 95%
-1.5 to 11.4
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 56
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
-5.9 to 7.1
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 56
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 3.0
Confidence Interval (2-Sided) 95%
-3.1 to 9.7
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 60
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-6.5 to 6.5
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 60
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 4.9
Confidence Interval (2-Sided) 95%
-1.3 to 11.4
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 64
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 3.7
Confidence Interval (2-Sided) 95%
-2.9 to 10.2
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 64
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 5.8
Confidence Interval (2-Sided) 95%
-0.4 to 12.3
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 68
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 2.4
Confidence Interval (2-Sided) 95%
-4.2 to 9.0
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 68
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 5.6
Confidence Interval (2-Sided) 95%
-0.2 to 11.9
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 72
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 3.8
Confidence Interval (2-Sided) 95%
-3.0 to 9.9
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 72
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 5.1
Confidence Interval (2-Sided) 95%
-1.1 to 11.4
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 76
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 6.0
Confidence Interval (2-Sided) 95%
-1.5 to 12.8
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 76
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 5.0
Confidence Interval (2-Sided) 95%
-1.0 to 11.6
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 80
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 1.7
Confidence Interval (2-Sided) 95%
-5.1 to 8.6
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 80
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 8.8
Confidence Interval (2-Sided) 95%
2.7 to 15.4
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 84
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 3.3
Confidence Interval (2-Sided) 95%
-3.7 to 9.4
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 42
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 84
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 4.2
Confidence Interval (2-Sided) 95%
-2.2 to 10.3
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 43
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 88
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 4.1
Confidence Interval (2-Sided) 95%
-3.0 to 10.9
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 44
Statistical Analysis Overview Comparison Group Selection Brolucizumab 6 mg, Aflibercept 2 mg
Comments Week 88
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 8.0
Confidence Interval (2-Sided) 95%
1.9 to 14.6
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
Hide Statistical Analysis 45
Statistical Analysis Overview Comparison Group Selection Brolucizumab 3 mg, Aflibercept 2 mg
Comments Week 92
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Hypothesis testing not pre-specified.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 1.6
Confidence Interval (2-Sided) 95%
-5.1 to 8.3
Estimation Comments Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.