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Trial record 1 of 2 for:    regeneron r2176
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Study of Intravitreal REGN2176-3 in Participants With Neovascular ("Wet") Age-Related Macular Degeneration (AMD) (CAPELLA)

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: NCT02418754
Recruitment Status : Terminated (No additional efficacy seen with REGN2176-3 over aflibercept alone)
First Posted : April 16, 2015
Results First Posted : October 26, 2020
Last Update Posted : October 26, 2020
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Neovascular Age-Related Macular Degeneration
Interventions Drug: REGN2176-3
Drug: Intravitreal Aflibercept Injection (IAI)
Enrollment 505
Recruitment Details The study was conducted at 82 sites in US and 11 sites in Japan. A total of 804 participants were screened. Out of 804 participants, 505 were randomized and treated.
Pre-assignment Details Participants were initially randomized in a 1:2:2 ratio to receive REGN2176-3 (1 mg:2 mg) (REGN2176 1 mg:REGN3 2 mg) or REGN2176-3 (3 mg:2 mg) (REGN2176 3 mg:REGN3 2 mg) or 2 mg intravitreal aflibercept injection (IAI). One eye was under study (the fellow eye was assessed for safety only).
Arm/Group Title Group 1: REGN2176-3 (1 mg:2 mg) Group 2: REGN2176-3 (3 mg:2 mg) Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg Group 4: REGN2176-3 (3 mg:2 mg) to IAI 2 mg Group 5: IAI 2 mg to REGN2176-3 (3 mg:2 mg)
Hide Arm/Group Description Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, Group 1 continued without a secondary randomization. After Week 12, dosing in Group 1 was monthly up to Week 28, then criteria based re-dosing from Week 28-52. Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 2 was monthly up to Week 28, then criteria based re-dosing from Week 28-52. IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 3 was monthly up to Week 28, then criteria based re-dosing from Week 28-52. Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 4 was monthly with IAI 2 mg up to Week 28, then criteria based re-dosing from Week 28-52. IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 5 was monthly with REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) up to Week 28, then criteria based re-dosing from Week 28-52.
Period Title: Period 1 (Day 1 to Week 12)
Number of participants Number of units (Study Eyes) Number of participants Number of units (Study Eyes) Number of participants Number of units (Study Eyes) Number of participants Number of units (Study Eyes) Number of participants Number of units (Study Eyes)
Started [1] 103 103 200 200 202 202 0 0 0 0
Completed [2] 101 101 196 196 200 200 0 0 0 0
Not Completed 2 2 4 4 2 2 0 0 0 0
Reason Not Completed
Adverse Event             0                         2                         0                         0                         0            
Death             1                         0                         0                         0                         0            
Physician Decision             1                         0                         0                         0                         0            
Withdrawal by Subject             0                         2                         1                         0                         0            
Lost to Follow-up             0                         0                         1                         0                         0            
[1]
Safety Analysis Set (SAF): all initially randomized participants who received any study drug
[2]
Completed week 12 in the SAF
Period Title: Period 2 (Day 1 to Week 52/End of Study)
Number of participants Number of units (Study Eyes) Number of participants Number of units (Study Eyes) Number of participants Number of units (Study Eyes) Number of participants Number of units (Study Eyes) Number of participants Number of units (Study Eyes)
Started [1] 103 103 106 106 108 108 94 94 94 94
Completed [2] 70 70 64 64 71 71 67 67 67 67
Not Completed 33 33 42 42 37 37 27 27 27 27
Reason Not Completed
Adverse Event             3                         7                         6                         2                         2            
Death             1                         0                         0                         0                         0            
Physician Decision             26                         28                         26                         21                         24            
Withdrawal by Subject             3                         4                         4                         1                         0            
Lost to Follow-up             0                         2                         1                         2                         1            
Other Un-specified             0                         1                         0                         1                         0            
[1]
SAF (includes all initially randomized participants who received any study drug)
[2]
Completed week 52 in the SAF
Arm/Group Title Group 1: REGN2176-3 (1 mg:2 mg) Group 2: REGN2176-3 (3 mg:2 mg) Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg Total
Hide Arm/Group Description Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, Group 1 continued without a secondary randomization. After Week 12, dosing in Group 1 was monthly up to Week 28, then criteria based re-dosing from Week 28-52. Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 2 was monthly up to Week 28, then criteria based re-dosing from Week 28-52. IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 3 was monthly up to Week 28, then criteria based re-dosing from Week 28-52. Total of all reporting groups
Overall Number of Baseline Participants 103 200 202 505
Hide Baseline Analysis Population Description
Baseline population included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 103 participants 200 participants 202 participants 505 participants
79.2  (8.01) 78.6  (8.77) 77.7  (8.61) 78.3  (8.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants 200 participants 202 participants 505 participants
Female
61
  59.2%
121
  60.5%
135
  66.8%
317
  62.8%
Male
42
  40.8%
79
  39.5%
67
  33.2%
188
  37.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants 200 participants 202 participants 505 participants
Hispanic or Latino
1
   1.0%
7
   3.5%
6
   3.0%
14
   2.8%
Not Hispanic or Latino
102
  99.0%
193
  96.5%
196
  97.0%
491
  97.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants 200 participants 202 participants 505 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   0.5%
1
   0.2%
Asian
5
   4.9%
9
   4.5%
10
   5.0%
24
   4.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   0.5%
2
   1.0%
3
   0.6%
White
98
  95.1%
189
  94.5%
186
  92.1%
473
  93.7%
More than one race
0
   0.0%
1
   0.5%
1
   0.5%
2
   0.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
2
   1.0%
2
   0.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 103 participants 200 participants 202 participants 505 participants
United States 98 193 194 485
Japan 5 7 8 20
1.Primary Outcome
Title Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye at Week 12
Hide Description Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. BCVA score was measured using an eye chart and was reported as the number of letters read correctly at a testing distance of 4 meters using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Change from baseline calculated by subtracting baseline value from observed post-baseline value at Week 12.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) that included all randomized participants who received any study treatment, had a baseline measurement of BCVA, and at least 1 post-baseline assessment of BCVA. Last observation carried forward (LOCF) method was used to impute missing data.
Arm/Group Title Group 1: REGN2176-3 (1 mg:2 mg) Group 2: REGN2176-3 (3 mg:2 mg) Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg
Hide Arm/Group Description:
Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, Group 1 continued without a secondary randomization. After Week 12, dosing in Group 1 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 2 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 3 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
Overall Number of Participants Analyzed 103 200 202
Least Squares Mean (Standard Error)
Unit of Measure: Letters
5.9  (1.01) 5.7  (0.73) 7.4  (0.72)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: REGN2176-3 (1 mg:2 mg), Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg
Comments To control for the family-wise type I error rate of 5%, for each of the 2 REGN2176-3 groups the 2-sided hypothesis comparing REGN2176-3 (1 mg: 2 mg) vs. Intravitreal Aflibercept Injection (IAI) 2 mg was tested at a significance level of α = 2.5%.
Type of Statistical Test Superiority
Comments Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurements as covariate and treatment group, baseline angiographic choroidal neovascularization (CNV) subtype (predominantly or minimally classic versus occult versus occult with no classic lesions) as fixed factors.
Statistical Test of Hypothesis P-Value 0.2052
Comments Threshold for significance at 0.025 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares (LS) Mean Difference
Estimated Value -1.58
Confidence Interval (2-Sided) 95%
-4.37 to 1.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 2: REGN2176-3 (3 mg:2 mg), Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg
Comments To control for the family-wise type I error rate of 5%, for each of the 2 REGN2176-3 groups the 2-sided hypothesis comparing REGN2176-3 (1 mg: 2 mg) vs. Intravitreal Aflibercept Injection (IAI) 2 mg was tested at a significance level of α = 2.5%.
Type of Statistical Test Superiority
Comments Analysis was performed using ANCOVA model with baseline measurements as covariate and treatment group, baseline angiographic choroidal neovascularization (CNV) subtype (predominantly or minimally classic versus occult versus occult with no classic lesions) as fixed factors.
Statistical Test of Hypothesis P-Value 0.0982
Comments Threshold for significance at 0.025 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares (LS) Mean Difference
Estimated Value -1.70
Confidence Interval (2-Sided) 95%
-4.00 to 0.61
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Central Subfield Retinal Thickness (CST) at Week 12, as Measured by Optical Coherence Tomography (OCT)
Hide Description CST was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from baseline indicated improvement. Change from baseline calculated by subtracting baseline value from LOCF post-baseline value at Week 12.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS. LOCF method was used to impute missing data.
Arm/Group Title Group 1: REGN2176-3 (1 mg:2 mg) Group 2: REGN2176-3 (3 mg:2 mg) Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg
Hide Arm/Group Description:
Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, Group 1 continued without a secondary randomization. After Week 12, dosing in Group 1 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 2 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 3 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
Overall Number of Participants Analyzed 103 200 202
Least Squares Mean (Standard Error)
Unit of Measure: Microns
-131.1  (6.88) -116.9  (4.96) -134.4  (4.92)
3.Secondary Outcome
Title Percentage of Participants With Complete Resolution of Intraretinal and Subretinal Fluid From Baseline at Week 12 Measured by Optical Coherence Tomography (OCT)
Hide Description CST was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS. LOCF method was used to impute missing data.
Arm/Group Title Group 1: REGN2176-3 (1 mg:2 mg) Group 2: REGN2176-3 (3 mg:2 mg) Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg
Hide Arm/Group Description:
Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, Group 1 continued without a secondary randomization. After Week 12, dosing in Group 1 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 2 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 3 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
Overall Number of Participants Analyzed 103 200 202
Measure Type: Number
Unit of Measure: Percentage of Participants
35.0 24.0 42.1
4.Secondary Outcome
Title Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 12 Measured by Fluorescein Angiography (FA)
Hide Description The anatomical state of the retinal vasculature of the study eye and the fellow eye was evaluated by funduscopic examination, fundus photography and FA to evaluate the total lesion area, CNV area, classic CNV area, and fluorescein leakage. CNV area values measured in square millimeters, each disc area was equivalent to 2.54 mm^2 on the retina; lower values represent better outcomes.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS. LOCF was used to impute missing data. Here, number of participants analyzed = participants with available data for this outcome measure.
Arm/Group Title Group 1: REGN2176-3 (1 mg:2 mg) Group 2: REGN2176-3 (3 mg:2 mg) Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg
Hide Arm/Group Description:
Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, Group 1 continued without a secondary randomization. After Week 12, dosing in Group 1 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 2 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 3 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
Overall Number of Participants Analyzed 97 187 192
Least Squares Mean (Standard Error)
Unit of Measure: Square Millimeter (mm^2)
-3.4  (0.44) -2.0  (0.31) -3.6  (0.31)
5.Secondary Outcome
Title Change From Baseline in Total Lesion Size at Week 12 Measured by Fluorescein Angiography (FA)
Hide Description Total Lesion Size was assessed by Fluorescein Angiography.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS. LOCF was used to impute missing data. Here, number of participants analyzed = participants with available data for this outcome measure.
Arm/Group Title Group 1: REGN2176-3 (1 mg:2 mg) Group 2: REGN2176-3 (3 mg:2 mg) Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg
Hide Arm/Group Description:
Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, Group 1 continued without a secondary randomization. After Week 12, dosing in Group 1 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 2 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 3 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
Overall Number of Participants Analyzed 97 187 192
Least Squares Mean (Standard Error)
Unit of Measure: mm
-3.1  (0.43) -2.1  (0.31) -3.5  (0.31)
6.Secondary Outcome
Title Percentage of Participants Who Gained At Least 15 Letters in BCVA From Baseline at Week 12, Measured by 4-meter Early Treatment Diabetic Retinopathy Scale (ETDRS)
Hide Description Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. BCVA score was measured using an eye chart and was reported as the number of letters read correctly at a testing distance of 4 meters using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. This outcome assessed the percentage of participants who gained 15 or more letters of visual acuity at Week 12 compared with baseline.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS. LOCF was used to impute missing data.
Arm/Group Title Group 1: REGN2176-3 (1 mg:2 mg) Group 2: REGN2176-3 (3 mg:2 mg) Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg
Hide Arm/Group Description:
Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, Group 1 continued without a secondary randomization. After Week 12, dosing in Group 1 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 2 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 3 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
Overall Number of Participants Analyzed 103 200 202
Measure Type: Number
Unit of Measure: Percentage of Participants
11.7 18.5 21.8
7.Secondary Outcome
Title Percent Change From Baseline in Subretinal Hyperreflectivity Material (SHM) at Week 12 Measured by Optical Coherence Tomography (OCT)
Hide Description SHM was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from baseline indicated improvement.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS. LOCF was used to impute missing data. Here, number of participants analyzed = participants with available data for this outcome measure.
Arm/Group Title Group 1: REGN2176-3 (1 mg:2 mg) Group 2: REGN2176-3 (3 mg:2 mg) Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg
Hide Arm/Group Description:
Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, Group 1 continued without a secondary randomization. After Week 12, dosing in Group 1 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 2 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 3 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
Overall Number of Participants Analyzed 94 191 193
Least Squares Mean (Standard Error)
Unit of Measure: Percent change
-50.0  (5.94) -41.9  (4.17) -48.8  (4.14)
8.Secondary Outcome
Title Change From Baseline in Central Retinal/Lesion Thickness at Week 12 Measured by Optical Coherence Tomography (OCT)
Hide Description CST was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from baseline indicated improvement. Change from baseline calculated by subtracting baseline value from LOCF post-baseline value at Week 12.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS. LOCF was used to impute missing data.
Arm/Group Title Group 1: REGN2176-3 (1 mg:2 mg) Group 2: REGN2176-3 (3 mg:2 mg) Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg
Hide Arm/Group Description:
Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, Group 1 continued without a secondary randomization. After Week 12, dosing in Group 1 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 2 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 3 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
Overall Number of Participants Analyzed 103 200 202
Least Squares Mean (Standard Error)
Unit of Measure: Microns
-150.7  (7.40) -139.6  (5.32) -160.4  (5.29)
Time Frame All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product.
Adverse Event Reporting Description Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
 
Arm/Group Title Group 1: REGN2176-3 (1 mg:2 mg) Group 2: REGN2176-3 (3 mg:2 mg) Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg Group 4: REGN2176-3 (3 mg:2 mg) to IAI 2 mg Group 5: IAI 2 mg to REGN2176-3 (3 mg:2 mg)
Hide Arm/Group Description Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, Group 1 continued without a secondary randomization. After Week 12, dosing in Group 1 was monthly up to Week 28, then criteria based re-dosing from Week 28-52. Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 2 was monthly up to Week 28, then criteria based re-dosing from Week 28-52. IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 3 was monthly up to Week 28, then criteria based re-dosing from Week 28-52. Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 4 was monthly with IAI 2 mg up to Week 28, then criteria based re-dosing from Week 28-52. IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 5 was monthly with REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) up to Week 28, then criteria based re-dosing from Week 28-52.
All-Cause Mortality
Group 1: REGN2176-3 (1 mg:2 mg) Group 2: REGN2176-3 (3 mg:2 mg) Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg Group 4: REGN2176-3 (3 mg:2 mg) to IAI 2 mg Group 5: IAI 2 mg to REGN2176-3 (3 mg:2 mg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/103 (2.91%)      2/106 (1.89%)      3/108 (2.78%)      1/94 (1.06%)      1/94 (1.06%)    
Hide Serious Adverse Events
Group 1: REGN2176-3 (1 mg:2 mg) Group 2: REGN2176-3 (3 mg:2 mg) Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg Group 4: REGN2176-3 (3 mg:2 mg) to IAI 2 mg Group 5: IAI 2 mg to REGN2176-3 (3 mg:2 mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/103 (16.50%)      20/106 (18.87%)      23/108 (21.30%)      17/94 (18.09%)      15/94 (15.96%)    
Blood and lymphatic system disorders           
Anaemia  1  1/103 (0.97%)  1 0/106 (0.00%)  0 0/108 (0.00%)  0 0/94 (0.00%)  0 1/94 (1.06%)  1
Cardiac disorders           
Acute coronary syndrome  1  1/103 (0.97%)  1 0/106 (0.00%)  0 0/108 (0.00%)  0 0/94 (0.00%)  0 0/94 (0.00%)  0
Acute myocardial infarction  1  1/103 (0.97%)  1 1/106 (0.94%)  1 0/108 (0.00%)  0 1/94 (1.06%)  1 1/94 (1.06%)  1
Atrial fibrillation  1  1/103 (0.97%)  1 1/106 (0.94%)  1 0/108 (0.00%)  0 4/94 (4.26%)  4 1/94 (1.06%)  1
Bradycardia  1  0/103 (0.00%)  0 0/106 (0.00%)  0 1/108 (0.93%)  1 1/94 (1.06%)  1 0/94 (0.00%)  0
Cardiac failure congestive  1  3/103 (2.91%)  3 0/106 (0.00%)  0 0/108 (0.00%)  0 1/94 (1.06%)  1 0/94 (0.00%)  0
Cardio-Respiratory arrest  1  1/103 (0.97%)  1 0/106 (0.00%)  0 0/108 (0.00%)  0 0/94 (0.00%)  0 0/94 (0.00%)  0
Cardiomyopathy  1  0/103 (0.00%)  0 0/106 (0.00%)  0 0/108 (0.00%)  0 1/94 (1.06%)  1 0/94 (0.00%)  0
Coronary artery disease  1  0/103 (0.00%)  0 0/106 (0.00%)  0 1/108 (0.93%)  1 0/94 (0.00%)  0 0/94 (0.00%)  0
Ischaemic cardiomyopathy  1  1/103 (0.97%)  1 0/106 (0.00%)  0 0/108 (0.00%)  0 0/94 (0.00%)  0 0/94 (0.00%)  0
Pericardial effusion  1  1/103 (0.97%)  1 0/106 (0.00%)  0 0/108 (0.00%)  0 0/94 (0.00%)  0 0/94 (0.00%)  0
Stress cardiomyopathy  1  1/103 (0.97%)  1 0/106 (0.00%)  0 0/108 (0.00%)  0 0/94 (0.00%)  0 0/94 (0.00%)  0
Eye disorders           
Blindness  1 [1]  1/103 (0.97%)  1 0/106 (0.00%)  0 0/108 (0.00%)  0 0/94 (0.00%)  0 0/94 (0.00%)  0
Blindness transient  1 [1]  1/103 (0.97%)  1 0/106 (0.00%)  0 0/108 (0.00%)  0 0/94 (0.00%)  0 0/94 (0.00%)  0
Macular degeneration  1 [1]  0/103 (0.00%)  0 0/106 (0.00%)  0 1/108 (0.93%)  1 0/94 (0.00%)  0 0/94 (0.00%)  0
Neovascular age-related macular degeneration  1 [1]  0/103 (0.00%)  0 0/106 (0.00%)  0 1/108 (0.93%)  1 0/94 (0.00%)  0 0/94 (0.00%)  0
Open angle glaucoma  1 [1]  0/103 (0.00%)  0 0/106 (0.00%)  0 1/108 (0.93%)  1 0/94 (0.00%)  0 0/94 (0.00%)  0
Retinal haemorrhage  1 [1]  0/103 (0.00%)  0 0/106 (0.00%)  0 0/108 (0.00%)  0 0/94 (0.00%)  0 2/94 (2.13%)  2
Uveitis  1 [1]  1/103 (0.97%)  2 2/106 (1.89%)  2 0/108 (0.00%)  0 1/94 (1.06%)  1 0/94 (0.00%)  0
Visual acuity reduced  1 [1]  2/103 (1.94%)  2 1/106 (0.94%)  1 0/108 (0.00%)  0 0/94 (0.00%)  0 1/94 (1.06%)  1
Neovascular age-related macular degeneration  1 [2]  1/103 (0.97%)  1 0/106 (0.00%)  0 0/108 (0.00%)  0 0/94 (0.00%)  0 0/94 (0.00%)  0
Gastrointestinal disorders           
Ileus  1  0/103 (0.00%)  0 1/106 (0.94%)  1 0/108 (0.00%)  0 0/94 (0.00%)  0 0/94 (0.00%)  0
Intestinal obstruction  1  0/103 (0.00%)  0 1/106 (0.94%)  1 0/108 (0.00%)  0 0/94 (0.00%)  0 0/94 (0.00%)  0
Large intestine polyp  1  0/103 (0.00%)  0 0/106 (0.00%)  0 1/108 (0.93%)  1 0/94 (0.00%)  0 0/94 (0.00%)  0
General disorders           
Chest pain  1  0/103 (0.00%)  0 1/106 (0.94%)  1 0/108 (0.00%)  0 0/94 (0.00%)  0 0/94 (0.00%)  0
Death  1  1/103 (0.97%)  1 0/106 (0.00%)  0 0/108 (0.00%)  0 0/94 (0.00%)  0 0/94 (0.00%)  0
Non-Cardiac chest pain  1  0/103 (0.00%)  0 1/106 (0.94%)  1 0/108 (0.00%)  0 0/94 (0.00%)  0 0/94 (0.00%)  0
Hepatobiliary disorders           
Hepatitis acute  1  1/103 (0.97%)  1 0/106 (0.00%)  0 0/108 (0.00%)  0 0/94 (0.00%)  0 0/94 (0.00%)  0
Infections and infestations           
Bronchitis  1  0/103 (0.00%)  0 0/106 (0.00%)  0 2/108 (1.85%)  2 0/94 (0.00%)  0 0/94 (0.00%)  0
Device related infection  1  1/103 (0.97%)  1 0/106 (0.00%)  0 0/108 (0.00%)  0 0/94 (0.00%)  0 0/94 (0.00%)  0
Diverticulitis  1  1/103 (0.97%)  1 1/106 (0.94%)  1 0/108 (0.00%)  0 0/94 (0.00%)  0 1/94 (1.06%)  1
Endophthalmitis  1 [1]  0/103 (0.00%)  0 0/106 (0.00%)  0 0/108 (0.00%)  0 1/94 (1.06%)  1 0/94 (0.00%)  0
Gastroenteritis  1  0/103 (0.00%)  0 0/106 (0.00%)  0 1/108 (0.93%)  1 0/94 (0.00%)  0 0/94 (0.00%)  0
Infectious colitis  1  1/103 (0.97%)  1 0/106 (0.00%)  0 0/108 (0.00%)  0 0/94 (0.00%)  0 0/94 (0.00%)  0
Osteomyelitis  1  0/103 (0.00%)  0 1/106 (0.94%)  1 0/108 (0.00%)  0 1/94 (1.06%)  1 0/94 (0.00%)  0
Pneumonia  1  1/103 (0.97%)  1 1/106 (0.94%)  1 0/108 (0.00%)  0 3/94 (3.19%)  3 1/94 (1.06%)  1
Sepsis  1  0/103 (0.00%)  0 2/106 (1.89%)  2 0/108 (0.00%)  0 1/94 (1.06%)  1 1/94 (1.06%)  1
Staphylococcal bacteraemia  1  1/103 (0.97%)  2 1/106 (0.94%)  1 0/108 (0.00%)  0 0/94 (0.00%)  0 0/94 (0.00%)  0
Urinary tract infection  1  0/103 (0.00%)  0 1/106 (0.94%)  1 0/108 (0.00%)  0 0/94 (0.00%)  0 1/94 (1.06%)  1
Vestibular neuronitis  1  1/103 (0.97%)  1 0/106 (0.00%)  0 0/108 (0.00%)  0 0/94 (0.00%)  0 0/94 (0.00%)  0
Injury, poisoning and procedural complications           
Ankle fracture  1  0/103 (0.00%)  0 0/106 (0.00%)  0 1/108 (0.93%)  1 0/94 (0.00%)  0 0/94 (0.00%)  0
Back injury  1  1/103 (0.97%)  1 0/106 (0.00%)  0 0/108 (0.00%)  0 0/94 (0.00%)  0 0/94 (0.00%)  0
Comminuted fracture  1  0/103 (0.00%)  0 0/106 (0.00%)  0 0/108 (0.00%)  0 1/94 (1.06%)  1 0/94 (0.00%)  0
Fall  1  0/103 (0.00%)  0 2/106 (1.89%)  2 1/108 (0.93%)  1 3/94 (3.19%)  3 1/94 (1.06%)  1
Femur fracture  1  0/103 (0.00%)  0 2/106 (1.89%)  2 0/108 (0.00%)  0 0/94 (0.00%)  0 1/94 (1.06%)  1
Humerus fracture  1  0/103 (0.00%)  0 0/106 (0.00%)  0 1/108 (0.93%)  1 0/94 (0.00%)  0 0/94 (0.00%)  0
Impacted fracture  1  0/103 (0.00%)  0 1/106 (0.94%)  1 0/108 (0.00%)  0 0/94 (0.00%)  0 0/94 (0.00%)  0
Procedural pain  1  0/103 (0.00%)  0 0/106 (0.00%)  0 0/108 (0.00%)  0 1/94 (1.06%)  1 0/94 (0.00%)  0
Subdural haematoma  1  0/103 (0.00%)  0 0/106 (0.00%)  0 0/108 (0.00%)  0 0/94 (0.00%)  0 1/94 (1.06%)  1
Toxicity to various agents  1  0/103 (0.00%)  0 0/106 (0.00%)  0 0/108 (0.00%)  0 1/94 (1.06%)  1 0/94 (0.00%)  0
Investigations           
Blood pressure increased  1  0/103 (0.00%)  0 1/106 (0.94%)  1 0/108 (0.00%)  0 0/94 (0.00%)  0 0/94 (0.00%)  0
Metabolism and nutrition disorders           
Dehydration  1  0/103 (0.00%)  0 0/106 (0.00%)  0 1/108 (0.93%)  1 1/94 (1.06%)  1 0/94 (0.00%)  0
Hypercalcaemia  1  0/103 (0.00%)  0 0/106 (0.00%)  0 1/108 (0.93%)  1 0/94 (0.00%)  0 0/94 (0.00%)  0
Hypokalaemia  1  0/103 (0.00%)  0 0/106 (0.00%)  0 0/108 (0.00%)  0 0/94 (0.00%)  0 1/94 (1.06%)  1
Hyponatraemia  1  0/103 (0.00%)  0 0/106 (0.00%)  0 0/108 (0.00%)  0 1/94 (1.06%)  1 1/94 (1.06%)  1
Musculoskeletal and connective tissue disorders           
Arthralgia  1  0/103 (0.00%)  0 0/106 (0.00%)  0 0/108 (0.00%)  0 0/94 (0.00%)  0 1/94 (1.06%)  1
Intervertebral disc protrusion  1  0/103 (0.00%)  0 0/106 (0.00%)  0 0/108 (0.00%)  0 0/94 (0.00%)  0 1/94 (1.06%)  1
Muscle haemorrhage  1  0/103 (0.00%)  0 0/106 (0.00%)  0 0/108 (0.00%)  0 1/94 (1.06%)  1 0/94 (0.00%)  0
Muscular weakness  1  0/103 (0.00%)  0 0/106 (0.00%)  0 1/108 (0.93%)  1 0/94 (0.00%)  0 0/94 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Bladder cancer  1  0/103 (0.00%)  0 0/106 (0.00%)  0 0/108 (0.00%)  0 0/94 (0.00%)  0 1/94 (1.06%)  1
Breast cancer  1  0/103 (0.00%)  0 0/106 (0.00%)  0 1/108 (0.93%)  1 1/94 (1.06%)  1 1/94 (1.06%)  1
Gastric cancer  1  0/103 (0.00%)  0 0/106 (0.00%)  0 2/108 (1.85%)  2 0/94 (0.00%)  0 0/94 (0.00%)  0
Leukaemia  1  0/103 (0.00%)  0 1/106 (0.94%)  1 0/108 (0.00%)  0 0/94 (0.00%)  0 0/94 (0.00%)  0
Lip squamous cell carcinoma  1  0/103 (0.00%)  0 0/106 (0.00%)  0 1/108 (0.93%)  1 0/94 (0.00%)  0 0/94 (0.00%)  0
Lung adenocarcinoma  1  0/103 (0.00%)  0 1/106 (0.94%)  1 0/108 (0.00%)  0 0/94 (0.00%)  0 0/94 (0.00%)  0
Lung neoplasm malignant  1  0/103 (0.00%)  0 1/106 (0.94%)  1 2/108 (1.85%)  2 0/94 (0.00%)  0 0/94 (0.00%)  0
Non-Small cell lung cancer  1  0/103 (0.00%)  0 0/106 (0.00%)  0 1/108 (0.93%)  1 0/94 (0.00%)  0 0/94 (0.00%)  0
Oesophageal carcinoma  1  0/103 (0.00%)  0 0/106 (0.00%)  0 1/108 (0.93%)  1 0/94 (0.00%)  0 0/94 (0.00%)  0
Prostate cancer stage ii  1  0/103 (0.00%)  0 0/106 (0.00%)  0 0/108 (0.00%)  0 1/94 (1.06%)  1 0/94 (0.00%)  0
Squamous cell carcinoma  1 [1]  1/103 (0.97%)  1 0/106 (0.00%)  0 0/108 (0.00%)  0 0/94 (0.00%)  0 0/94 (0.00%)  0
Squamous cell carcinoma of skin  1  1/103 (0.97%)  1 0/106 (0.00%)  0 1/108 (0.93%)  1 1/94 (1.06%)  1 0/94 (0.00%)  0
Squamous cell carcinoma  1  0/103 (0.00%)  0 0/106 (0.00%)  0 1/108 (0.93%)  1 0/94 (0.00%)  0 0/94 (0.00%)  0
Nervous system disorders           
Basal ganglia stroke  1  0/103 (0.00%)  0 0/106 (0.00%)  0 1/108 (0.93%)  1 0/94 (0.00%)  0 0/94 (0.00%)  0
Carotid artery stenosis  1  0/103 (0.00%)  0 0/106 (0.00%)  0 0/108 (0.00%)  0 1/94 (1.06%)  1 1/94 (1.06%)  1
Cerebrovascular accident  1  0/103 (0.00%)  0 1/106 (0.94%)  1 1/108 (0.93%)  1 0/94 (0.00%)  0 0/94 (0.00%)  0
Dementia alzheimer's type  1  0/103 (0.00%)  0 0/106 (0.00%)  0 0/108 (0.00%)  0 1/94 (1.06%)  1 0/94 (0.00%)  0
Dysarthria  1  0/103 (0.00%)  0 0/106 (0.00%)  0 0/108 (0.00%)  0 1/94 (1.06%)  1 0/94 (0.00%)  0
Encephalopathy  1  0/103 (0.00%)  0 0/106 (0.00%)  0 1/108 (0.93%)  1 1/94 (1.06%)  1 0/94 (0.00%)  0
Hypoaesthesia  1  1/103 (0.97%)  1 0/106 (0.00%)  0 0/108 (0.00%)  0 0/94 (0.00%)  0 0/94 (0.00%)  0
Metabolic encephalopathy  1  0/103 (0.00%)  0 0/106 (0.00%)  0 1/108 (0.93%)  1 0/94 (0.00%)  0 0/94 (0.00%)  0
Syncope  1  1/103 (0.97%)  1 0/106 (0.00%)  0 0/108 (0.00%)  0 0/94 (0.00%)  0 0/94 (0.00%)  0
Tremor  1  0/103 (0.00%)  0 0/106 (0.00%)  0 1/108 (0.93%)  1 0/94 (0.00%)  0 0/94 (0.00%)  0
Psychiatric disorders           
Major depression  1  0/103 (0.00%)  0 0/106 (0.00%)  0 0/108 (0.00%)  0 1/94 (1.06%)  1 0/94 (0.00%)  0
Renal and urinary disorders           
Acute kidney injury  1  0/103 (0.00%)  0 0/106 (0.00%)  0 0/108 (0.00%)  0 1/94 (1.06%)  1 1/94 (1.06%)  1
Calculus ureteric  1  0/103 (0.00%)  0 1/106 (0.94%)  1 0/108 (0.00%)  0 0/94 (0.00%)  0 0/94 (0.00%)  0
Haematuria  1  0/103 (0.00%)  0 0/106 (0.00%)  0 1/108 (0.93%)  1 0/94 (0.00%)  0 0/94 (0.00%)  0
Nephrolithiasis  1  0/103 (0.00%)  0 0/106 (0.00%)  0 0/108 (0.00%)  0 0/94 (0.00%)  0 1/94 (1.06%)  1
Respiratory, thoracic and mediastinal disorders           
Acute respiratory failure  1  0/103 (0.00%)  0 0/106 (0.00%)  0 1/108 (0.93%)  1 0/94 (0.00%)  0 0/94 (0.00%)  0
Aspiration  1  0/103 (0.00%)  0 0/106 (0.00%)  0 0/108 (0.00%)  0 1/94 (1.06%)  1 0/94 (0.00%)  0
Chronic obstructive pulmonary disease  1  1/103 (0.97%)  2 1/106 (0.94%)  1 0/108 (0.00%)  0 0/94 (0.00%)  0 1/94 (1.06%)  1
Epistaxis  1  0/103 (0.00%)  0 1/106 (0.94%)  1 0/108 (0.00%)  0 0/94 (0.00%)  0 0/94 (0.00%)  0
Pleural effusion  1  1/103 (0.97%)  2 0/106 (0.00%)  0 0/108 (0.00%)  0 0/94 (0.00%)  0 0/94 (0.00%)  0
Pulmonary embolism  1  0/103 (0.00%)  0 0/106 (0.00%)  0 1/108 (0.93%)  1 0/94 (0.00%)  0 0/94 (0.00%)  0
Vascular disorders           
Hypotension  1  0/103 (0.00%)  0 1/106 (0.94%)  1 1/108 (0.93%)  1 0/94 (0.00%)  0 0/94 (0.00%)  0
Peripheral ischaemia  1  0/103 (0.00%)  0 1/106 (0.94%)  1 0/108 (0.00%)  0 0/94 (0.00%)  0 0/94 (0.00%)  0
Shock haemorrhagic  1  0/103 (0.00%)  0 0/106 (0.00%)  0 0/108 (0.00%)  0 1/94 (1.06%)  1 0/94 (0.00%)  0
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
[1]
Study eye
[2]
Fellow eye
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1: REGN2176-3 (1 mg:2 mg) Group 2: REGN2176-3 (3 mg:2 mg) Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg Group 4: REGN2176-3 (3 mg:2 mg) to IAI 2 mg Group 5: IAI 2 mg to REGN2176-3 (3 mg:2 mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   48/103 (46.60%)      50/106 (47.17%)      51/108 (47.22%)      52/94 (55.32%)      52/94 (55.32%)    
Eye disorders           
Cataract  1 [1]  6/103 (5.83%)  6 1/106 (0.94%)  1 2/108 (1.85%)  2 1/94 (1.06%)  1 0/94 (0.00%)  0
Conjunctival haemorrhage  1 [2]  6/103 (5.83%)  6 4/106 (3.77%)  4 6/108 (5.56%)  7 11/94 (11.70%)  13 9/94 (9.57%)  12
Eye pain  1 [2]  3/103 (2.91%)  3 5/106 (4.72%)  6 1/108 (0.93%)  1 6/94 (6.38%)  9 2/94 (2.13%)  2
Neovascular age-related macular degeneration  1 [1]  1/103 (0.97%)  1 10/106 (9.43%)  10 8/108 (7.41%)  9 8/94 (8.51%)  8 5/94 (5.32%)  5
Posterior capsule opacification  1 [2]  1/103 (0.97%)  1 2/106 (1.89%)  2 1/108 (0.93%)  1 4/94 (4.26%)  4 5/94 (5.32%)  5
Retinal haemorrhage  1 [2]  6/103 (5.83%)  7 8/106 (7.55%)  8 3/108 (2.78%)  3 5/94 (5.32%)  5 3/94 (3.19%)  3
Vitreous detachment  1 [2]  3/103 (2.91%)  3 3/106 (2.83%)  4 2/108 (1.85%)  2 7/94 (7.45%)  7 3/94 (3.19%)  3
Vitreous floaters  1 [2]  2/103 (1.94%)  3 1/106 (0.94%)  1 1/108 (0.93%)  1 3/94 (3.19%)  3 10/94 (10.64%)  15
Posterior capsule opacification  1 [1]  5/103 (4.85%)  5 1/106 (0.94%)  1 2/108 (1.85%)  2 5/94 (5.32%)  5 2/94 (2.13%)  3
Vitreous floaters  1 [1]  2/103 (1.94%)  2 0/106 (0.00%)  0 0/108 (0.00%)  0 4/94 (4.26%)  5 5/94 (5.32%)  5
Gastrointestinal disorders           
Nausea  1  3/103 (2.91%)  3 0/106 (0.00%)  0 2/108 (1.85%)  2 2/94 (2.13%)  2 6/94 (6.38%)  7
Infections and infestations           
Nasopharyngitis  1  3/103 (2.91%)  3 6/106 (5.66%)  6 9/108 (8.33%)  12 5/94 (5.32%)  5 8/94 (8.51%)  8
Sinusitis  1  2/103 (1.94%)  3 7/106 (6.60%)  8 2/108 (1.85%)  2 4/94 (4.26%)  4 7/94 (7.45%)  7
Urinary tract infection  1  7/103 (6.80%)  8 7/106 (6.60%)  9 4/108 (3.70%)  4 7/94 (7.45%)  8 13/94 (13.83%)  17
Injury, poisoning and procedural complications           
Fall  1  5/103 (4.85%)  6 6/106 (5.66%)  6 2/108 (1.85%)  2 4/94 (4.26%)  4 3/94 (3.19%)  3
Vascular disorders           
Hypertension  1  6/103 (5.83%)  6 4/106 (3.77%)  4 10/108 (9.26%)  10 2/94 (2.13%)  2 5/94 (5.32%)  6
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
[1]
Fellow eye
[2]
Study eye
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trials Administrator
Organization: Regeneron Pharmaceuticals, Inc.
Phone: 844-734-6643
EMail: clinicaltrials@regeneron.com
Layout table for additonal information
Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02418754    
Obsolete Identifiers: NCT02603484
Other Study ID Numbers: R2176-3-AMD-1417
First Submitted: April 13, 2015
First Posted: April 16, 2015
Results First Submitted: September 1, 2020
Results First Posted: October 26, 2020
Last Update Posted: October 26, 2020