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A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (CHROMA)

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: NCT02247479
Recruitment Status : Terminated (Study terminated)
First Posted : September 25, 2014
Results First Posted : April 23, 2019
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Geographic Atrophy
Interventions Drug: Lampalizumab
Other: Sham
Enrollment 906
Recruitment Details A total of 906 participants were randomized to the study from 131 investigation sites across 19 countries. The study was terminated early by the Sponsor due to lack of efficacy.
Pre-assignment Details This study enrolled participants with bilateral Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD) and no signs of prior or active choroidal neovascularization (CNV), age >= 50 years with a valid complement factor I (CFI)-profile biomarker result.
Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
Hide Arm/Group Description Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit. Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit. Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
Period Title: Overall Study
Started 305 298 303
Completed 163 160 165
Not Completed 142 138 138
Reason Not Completed
Adverse Event             8             9             8
Death             5             4             6
Lost to Follow-up             3             3             1
Non-compliance             0             0             1
Withdrawal by Subject             25             29             24
Study Terminated by Sponsor             98             88             94
Physician Decision             1             0             2
Unspecified Reason             2             5             2
Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W Total
Hide Arm/Group Description Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit. Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit. Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit. Total of all reporting groups
Overall Number of Baseline Participants 305 298 303 906
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all the participants who were randomized to the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 305 participants 298 participants 303 participants 906 participants
78.5  (7.8) 77.5  (7.9) 78.3  (8.5) 78.1  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 305 participants 298 participants 303 participants 906 participants
Female
186
  61.0%
182
  61.1%
185
  61.1%
553
  61.0%
Male
119
  39.0%
116
  38.9%
118
  38.9%
353
  39.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 305 participants 298 participants 303 participants 906 participants
American Indian or Alaska Native
0
   0.0%
1
   0.3%
1
   0.3%
2
   0.2%
Native Hawaiian or other Pacific Islander
0
   0.0%
1
   0.3%
0
   0.0%
1
   0.1%
White
302
  99.0%
294
  98.7%
295
  97.4%
891
  98.3%
Multiple
0
   0.0%
0
   0.0%
1
   0.3%
1
   0.1%
Unknown
3
   1.0%
2
   0.7%
6
   2.0%
11
   1.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 305 participants 298 participants 303 participants 906 participants
Hispanic or Latino
20
   6.6%
17
   5.7%
18
   5.9%
55
   6.1%
Not Hispanic or Latino
279
  91.5%
278
  93.3%
282
  93.1%
839
  92.6%
Not Stated
2
   0.7%
3
   1.0%
1
   0.3%
6
   0.7%
Unknown
4
   1.3%
0
   0.0%
2
   0.7%
6
   0.7%
Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluoresence (FAF)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Millimeter square (mm^2)
Number Analyzed 305 participants 298 participants 302 participants 905 participants
7.953  (3.925) 7.910  (3.887) 8.116  (4.236) 7.993  (4.016)
[1]
Measure Description: At baseline the area of GA was assessed by FAF.
[2]
Measure Analysis Population Description: ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected.
Number of Absolute Scotomatous Points as Assessed by Mesopic Micrometry   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Absolute scotomatous points
Number Analyzed 44 participants 33 participants 39 participants 116 participants
29.1  (16.8) 25.2  (13.4) 20.5  (13.4) 25.1  (15.1)
[1]
Measure Description: Scotomatous points were the testing points on microperimetry examination that were centered on the macula and reported a lack of retinal sensitivity within the range tested, a maximum of 68 points were tested within this range. Higher results indicate expansion of absolute scotoma and higher number of abolute scotomatous points. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center.
[2]
Measure Analysis Population Description: The microperimetry analysis population consisted of all participants who met the microperimetry eligibility criteria assessed by the reading center (participants at selected sites only; participants grouped according to treatment assigned at randomization).
Macular Sensitivity as Assessed by Mesopic Microperimetry   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Decibel (dB)
Number Analyzed 44 participants 33 participants 39 participants 116 participants
5.40  (3.37) 6.37  (4.02) 7.38  (3.40) 6.34  (3.64)
[1]
Measure Description: Mesopic microperimetry was used to assess macular sensitivity and assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center.
[2]
Measure Analysis Population Description: The microperimetry analysis population consisted of all participants who met the microperimetry eligibility criteria assessed by the reading center (participants at selected sites only; participants grouped according to treatment assigned at randomization).
Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Letters
Number Analyzed 301 participants 295 participants 301 participants 897 participants
65.9  (9.9) 66.1  (10.0) 66.4  (10.1) 66.2  (10.0)
[1]
Measure Description: BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters. BCVA score testing was performed prior to dilating the eyes. BCVA score ranges 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).
[2]
Measure Analysis Population Description: ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected.
Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under Low Luminance Conditions   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Letters
Number Analyzed 299 participants 287 participants 293 participants 879 participants
36.0  (15.7) 36.9  (17.8) 36.2  (16.7) 36.4  (16.7)
[1]
Measure Description: The LLVA was measured by placing a 2.0-log-unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart. The assessment was performed prior to dilating the eyes. LLVA score ranges 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).
[2]
Measure Analysis Population Description: ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected.
Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test or Radner Reading Charts   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Words per minute (wpm)
Number Analyzed 278 participants 262 participants 269 participants 809 participants
106.89  (57.98) 109.18  (60.14) 104.22  (62.37) 106.74  (60.12)
[1]
Measure Description: Minnesota Low-Vision Reading (MNRead) acuity cards were continuous-text reading-acuity cards suitable for measuring reading acuity and reading speed of normal and low-vision participants. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. Reading test was stopped when reading time was longer than 20 seconds or when participant was making severe errors.
[2]
Measure Analysis Population Description: ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected.
National Eye Institute Visual Functioning Questionnaire 25-item (NEI VFQ-25) Version Composite Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 276 participants 275 participants 282 participants 833 participants
66.16  (17.33) 64.80  (16.12) 65.19  (17.27) 65.38  (16.91)
[1]
Measure Description: NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: near activities, distance activities, general health,general vision, ocular pain, vision−specific social functioning, vision−specific mental health, vision−specific role difficulties, vision−specific dependency, driving, color vision and peripheral vision. Response to each question converted to 0-100 score. Each subscale, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, a higher score represents better functioning.
[2]
Measure Analysis Population Description: ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected.
Mean Functional Reading Independence (FRI) Index   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 276 participants 273 participants 280 participants 829 participants
2.69  (0.83) 2.71  (0.79) 2.70  (0.82) 2.70  (0.81)
[1]
Measure Description: The FRI was an interviewer-administered questionnaire with 7-items on functional reading activities most relevant to GA AMD participants. It has one total index score. For each FRI Index reading activity performed in the past 7 days, participants were asked about the extent to which they required vision aids, adjustments in the activity, or help from another participant. Mean FRI Index scores range from 1 to 4, with higher scores indicating greater independence.
[2]
Measure Analysis Population Description: ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected.
NEI VFQ-25 Near Activity Subscale Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 276 participants 275 participants 282 participants 833 participants
54.98  (20.98) 53.78  (20.56) 53.67  (22.21) 54.14  (21.25)
[1]
Measure Description: NEI-VFQ-25 questionnaire included 25 items based on near activities, which are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning.
[2]
Measure Analysis Population Description: ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected.
NEI VFQ-25 Distance Activity Subscale Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 276 participants 275 participants 282 participants 833 participants
62.86  (21.46) 60.97  (20.48) 62.10  (22.16) 61.98  (21.37)
[1]
Measure Description: NEI-VFQ-25 questionnaire included 25 items based on which distance activities was measured. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning.
[2]
Measure Analysis Population Description: ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected.
Monocular Maximum Reading Speed as Assessed by MNRead Charts or Radner Reading Charts   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Wpm
Number Analyzed 278 participants 265 participants 271 participants 814 participants
80.89  (52.95) 85.18  (54.55) 79.49  (54.23) 81.82  (53.89)
[1]
Measure Description: MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. Reading test was stopped when reading time was longer than 20 seconds or when participant was making severe errors.
[2]
Measure Analysis Population Description: ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected.
GA Area in Complement Factor I (CFI) Positive Participants   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Mm^2
Number Analyzed 181 participants 176 participants 177 participants 534 participants
8.015  (3.915) 8.152  (4.118) 8.406  (4.399) 8.190  (4.142)
[1]
Measure Description: For CFI profile, positive biomarker status refers to the presence (carrier) of the risk allele at CFI and at least one risk allele at complement factor H (CFH) or risk locus containing both complement component 2 and complement factor B (C2/CFB).
[2]
Measure Analysis Population Description: ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected.
GA Area in CFI Negative Participants   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Mm^2
Number Analyzed 124 participants 122 participants 125 participants 371 participants
7.864  (3.952) 7.560  (3.515) 7.705  (3.975) 7.710  (3.814)
[1]
Measure Description: For CFI profile, negative biomarker status refers to the absence of the risk allele at CFI and at least one risk allele at CFH or C2/CFB.
[2]
Measure Analysis Population Description: ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected.
1.Primary Outcome
Title Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48
Hide Description The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in Mixed-effect model repeated measures (MMRM) analysis.
Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
Hide Arm/Group Description:
Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
Overall Number of Participants Analyzed 274 259 270
Mean (Standard Error)
Unit of Measure: millimeter square (mm^2)
2.035  (0.066) 2.016  (0.068) 2.086  (0.067)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q4W
Comments Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8381
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value -0.019
Confidence Interval (2-Sided) 95%
-0.206 to 0.167
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q6W
Comments Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5901
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value 0.051
Confidence Interval (2-Sided) 95%
-0.134 to 0.236
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in GA Area in Complement Factor I (CFI) Positive and Negative Participants at Week 48
Hide Description For CFI profile, positive or negative biomarker status refers to the presence (carrier) or absence of the risk allele at CFI and at least one risk allele at complement factor H (CFH) or risk locus containing both complement component 2 and complement factor B (C2/CFB).The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all the participants who were randomized to the study. The analysis was done specifically for CFI-positive and negative participants. Number analyzed for each row signifies the participants evaluated for specified categories for each reporting group.
Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
Hide Arm/Group Description:
Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
Overall Number of Participants Analyzed 305 298 303
Mean (Standard Error)
Unit of Measure: mm^2
CFI-Positive Participants Number Analyzed 162 participants 152 participants 160 participants
2.067  (0.086) 2.045  (0.089) 2.144  (0.087)
CFI-Negative Participants Number Analyzed 112 participants 107 participants 110 participants
2.006  (0.103) 1.974  (0.105) 2.012  (0.104)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q4W
Comments CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8612
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value -0.022
Confidence Interval (2-Sided) 95%
-0.266 to 0.223
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q6W
Comments CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5317
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value 0.077
Confidence Interval (2-Sided) 95%
-0.165 to 0.319
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q4W
Comments CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8240
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value -0.033
Confidence Interval (2-Sided) 95%
-0.322 to 0.257
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q6W
Comments CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9676
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value 0.006
Confidence Interval (2-Sided) 95%
-0.283 to 0.294
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Number of Absolute Scotomatous Points as Assessed by Mesopic Micrometry at Week 48
Hide Description Scotomatous points were the testing points on microperimetry examination that were centered on the macula and reported a lack of retinal sensitivity within the range tested, a maximum of 68 points were tested within this range. Higher results indicate expansion of absolute scotoma and higher number of abolute scotomatous points. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. A positive change from baseline indicates an increase in the number of absolute scotomatous points (more lack of retinal sensitivity); disease worsening.
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The microperimetry analysis population consisted of all participants who met the microperimetry eligibility criteria assessed by the reading center (participants at selected sites only; participants grouped according to treatment assigned at randomization). Participants analyzed in this outcome measure were those included in MMRM analysis.
Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
Hide Arm/Group Description:
Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
Overall Number of Participants Analyzed 30 26 26
Mean (Standard Error)
Unit of Measure: absolute scotomatous points
8.3  (1.7) 8.1  (1.8) 8.3  (1.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q4W
Comments Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9350
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-5.2 to 4.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q6W
Comments Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9789
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-5.0 to 5.2
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Mean Macular Sensitivity as Assessed by Mesopic Microperimetry at Week 48
Hide Description Mesopic microperimetry was used to assess macular sensitivity and assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. A negative change from baseline indicates a decrease in the mean macular sensitivity; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The microperimetry analysis population consisted of all participants who met the microperimetry eligibility criteria assessed by the reading center (participants at selected sites only; participants grouped according to treatment assigned at randomization). Participants analyzed in this outcome measure were those included in MMRM analysis.
Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
Hide Arm/Group Description:
Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
Overall Number of Participants Analyzed 30 26 26
Mean (Standard Error)
Unit of Measure: decibel (dB)
-1.61  (0.33) -1.33  (0.34) -2.24  (0.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q4W
Comments Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5538
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value 0.28
Confidence Interval (2-Sided) 95%
-0.66 to 1.22
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q6W
Comments Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2032
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value -0.63
Confidence Interval (2-Sided) 95%
-1.60 to 0.35
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Week 48
Hide Description BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters (m). BCVA score testing was performed prior to dilating the eyes. BCVA score ranges 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). A negative change from baseline indicates a decrease in the visual acuity; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.
Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
Hide Arm/Group Description:
Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
Overall Number of Participants Analyzed 267 259 261
Mean (Standard Error)
Unit of Measure: letters
-4.5  (0.6) -3.4  (0.6) -4.6  (0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q4W
Comments Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2547
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
-0.7 to 2.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q6W
Comments Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8423
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-1.9 to 1.6
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Less Than 15 Letters Loss From Baseline in BCVA Score at Week 48
Hide Description Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 meters (m). BCVA was measured using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all the participants who were randomized to the study. Reported here is the number of participants for whom data were collected.
Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
Hide Arm/Group Description:
Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
Overall Number of Participants Analyzed 267 259 262
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
85.8
(81.6 to 90.0)
88.8
(85.0 to 92.6)
87.0
(83.0 to 91.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q4W
Comments Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline BCVA, baseline GA lesion location, biomarker status, and sex.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3248
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
0.8 to 2.2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q6W
Comments Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline BCVA, baseline GA lesion location, biomarker status, and sex.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7209
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.7 to 1.8
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under Low Luminance Conditions at Week 48
Hide Description The LLVA was measured by placing a 2.0-log-unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart. The assessment was performed prior to dilating the eyes. LLVA score ranges 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). The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.
Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
Hide Arm/Group Description:
Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
Overall Number of Participants Analyzed 265 251 252
Mean (Standard Error)
Unit of Measure: letters
-3.0  (0.7) -2.4  (0.7) -2.7  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q4W
Comments Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5695
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
-1.4 to 2.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q6W
Comments Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7865
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-1.7 to 2.3
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants With Less Than 15 Letters Loss From Baseline in LLVA Score at Week 48
Hide Description Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 m. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all the participants who were randomized to the study. Reported here is the number of participants for whom data were collected.
Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
Hide Arm/Group Description:
Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
Overall Number of Participants Analyzed 265 251 253
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
86.8
(82.7 to 90.9)
85.3
(80.9 to 89.6)
86.6
(82.4 to 90.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q4W
Comments Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline LLVA, baseline GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9448
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.6 to 1.7
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q6W
Comments Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline LLVA, baseline GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8764
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.6 to 1.8
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test (MNRead) Charts or Radner Reading Charts at Week 48
Hide Description MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. The MNRead acuity cards consisted of single, simple sentences with equal numbers of characters. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. The Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. The reading test was stopped when the reading time was longer than 20 seconds or when the participant was making severe errors. A negative change from baseline indicates a decrease in the binocular reading speed; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.
Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
Hide Arm/Group Description:
Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
Overall Number of Participants Analyzed 242 223 229
Mean (Standard Error)
Unit of Measure: words per minute (wpm)
-18.97  (2.37) -13.32  (2.47) -19.96  (2.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q4W
Comments Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0991
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value 5.66
Confidence Interval (2-Sided) 95%
-1.07 to 12.38
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q6W
Comments Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7713
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value -0.99
Confidence Interval (2-Sided) 95%
-7.66 to 5.69
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Monocular Maximum Reading Speed as Assessed by MNRead Charts or Radner Reading Charts at Week 48
Hide Description MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. The MNRead acuity cards consisted of single, simple sentences with equal numbers of characters. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. The Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. The reading test was stopped when the reading time was longer than 20 seconds or when the participant was making severe errors. A negative change from baseline indicates a decrease in the monocular reading speed; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.
Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
Hide Arm/Group Description:
Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
Overall Number of Participants Analyzed 243 229 233
Mean (Standard Error)
Unit of Measure: wpm
-19.63  (2.41) -17.91  (2.49) -18.16  (2.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q4W
Comments MMRM analysis uses change as response variable included terms for treatment group, baseline maximum reading speed, type of reading charts, biomarker status, modified baseline BCVA and sex.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6204
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value 1.72
Confidence Interval (2-Sided) 95%
-5.09 to 8.53
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q6W
Comments MMRM analysis uses change as response variable included terms for treatment group, baseline maximum reading speed, type of reading charts, biomarker status, modified baseline BCVA and sex.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6705
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value 1.47
Confidence Interval (2-Sided) 95%
-5.31 to 8.25
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item (NEI VFQ-25) Version Composite Score at Week 48
Hide Description NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: near activities, distance activities, general health,general vision, ocular pain, vision−specific social functioning, vision−specific mental health, vision−specific role difficulties, vision−specific dependency, driving, color vision and peripheral vision. Response to each question converted to 0-100 score. Each subscale, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the visual functioning; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.
Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
Hide Arm/Group Description:
Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
Overall Number of Participants Analyzed 239 234 248
Mean (Standard Error)
Unit of Measure: scores on a scale
-1.31  (0.71) -1.66  (0.72) -2.87  (0.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q6W
Comments Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7246
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value -0.36
Confidence Interval (2-Sided) 95%
-2.35 to 1.64
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q6W
Comments Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1193
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value -1.56
Confidence Interval (2-Sided) 95%
-3.53 to 0.40
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in NEI VFQ-25 Near Activity Subscale Score at Week 48
Hide Description NEI-VFQ-25 questionnaire included 25 items based on which near activities were measured. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the near visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.
Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
Hide Arm/Group Description:
Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
Overall Number of Participants Analyzed 239 234 248
Mean (Standard Error)
Unit of Measure: score on a scale
-2.12  (0.93) -2.35  (0.94) -4.06  (0.92)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q4W
Comments Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8659
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-2.84 to 2.39
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q6W
Comments Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1399
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value -1.94
Confidence Interval (2-Sided) 95%
-4.51 to 0.64
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in NEI VFQ-25 Distance Activity Subscale Score at Week 48
Hide Description NEI-VFQ-25 questionnaire included 25 items based on which distance activities were measured. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the distance visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.
Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
Hide Arm/Group Description:
Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
Overall Number of Participants Analyzed 239 234 248
Mean (Standard Error)
Unit of Measure: score on a scale
-2.03  (0.99) -1.04  (1.00) -3.62  (0.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q4W
Comments Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4855
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
-1.79 to 3.76
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q6W
Comments Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2515
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value -1.60
Confidence Interval (2-Sided) 95%
-4.33 to 1.13
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Mean Functional Reading Independence (FRI) Index at Week 48
Hide Description The FRI was an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD participants. It has one total index score. For each FRI Index reading activity performed in the past 7 days, participants were asked about the extent to which they required vision aids, adjustments in the activity, or help from another participant. Mean FRI Index scores range from 1 to 4, with higher scores indicating greater independence. A negative change from baseline indicates a decrease in the FRI; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.
Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
Hide Arm/Group Description:
Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
Overall Number of Participants Analyzed 237 230 244
Mean (Standard Error)
Unit of Measure: score on a scale
-0.06  (0.04) -0.13  (0.04) -0.15  (0.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q4W
Comments Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2075
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.18 to 0.04
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q6W
Comments Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1222
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-0.19 to 0.02
Estimation Comments [Not Specified]
Time Frame Up to approximately 2 years
Adverse Event Reporting Description Safety population included all participants who received at least one dose of study drug.
 
Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
Hide Arm/Group Description Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit. Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit. Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
All-Cause Mortality
Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/300 (2.00%)   5/298 (1.68%)   6/303 (1.98%) 
Show Serious Adverse Events Hide Serious Adverse Events
Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   97/300 (32.33%)   118/298 (39.60%)   108/303 (35.64%) 
Blood and lymphatic system disorders       
Anaemia  1  1/300 (0.33%)  2/298 (0.67%)  0/303 (0.00%) 
Haemorrhagic anaemia  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Cardiac disorders       
Acute myocardial infarction  1  1/300 (0.33%)  3/298 (1.01%)  3/303 (0.99%) 
Angina pectoris  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Angina unstable  1  0/300 (0.00%)  1/298 (0.34%)  1/303 (0.33%) 
Arrhythmia  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Arteriosclerosis coronary artery  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Atrial fibrillation  1  3/300 (1.00%)  4/298 (1.34%)  3/303 (0.99%) 
Atrial flutter  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Atrioventricular block first degree  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Bradycardia  1  2/300 (0.67%)  0/298 (0.00%)  2/303 (0.66%) 
Cardiac arrest  1  1/300 (0.33%)  1/298 (0.34%)  0/303 (0.00%) 
Cardiac failure  1  1/300 (0.33%)  3/298 (1.01%)  0/303 (0.00%) 
Cardiac failure congestive  1  2/300 (0.67%)  3/298 (1.01%)  6/303 (1.98%) 
Coronary artery disease  1  4/300 (1.33%)  1/298 (0.34%)  2/303 (0.66%) 
Myocardial infarction  1  0/300 (0.00%)  1/298 (0.34%)  2/303 (0.66%) 
Myocardial ischaemia  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Palpitations  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Tachycardia  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Ventricular fibrillation  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Congenital, familial and genetic disorders       
Atrial septal defect  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Ear and labyrinth disorders       
Vertigo  1  1/300 (0.33%)  1/298 (0.34%)  1/303 (0.33%) 
Eye disorders       
Blindness transient  1  0/300 (0.00%)  2/298 (0.67%)  2/303 (0.66%) 
Borderline glaucoma  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Choroidal neovascularisation  1  2/300 (0.67%)  2/298 (0.67%)  1/303 (0.33%) 
Iritis  1  0/300 (0.00%)  1/298 (0.34%)  1/303 (0.33%) 
Neovascular age-related macular degeneration  1  3/300 (1.00%)  3/298 (1.01%)  3/303 (0.99%) 
Open angle glaucoma  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Retinal artery occlusion  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Retinal detachment  1  1/300 (0.33%)  2/298 (0.67%)  0/303 (0.00%) 
Retinal neovascularisation  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Retinal tear  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Visual acuity reduced  1  10/300 (3.33%)  12/298 (4.03%)  8/303 (2.64%) 
Visual acuity reduced transiently  1  0/300 (0.00%)  2/298 (0.67%)  1/303 (0.33%) 
Vitreous haemorrhage  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Vitritis  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Dry age−related macular degeneration  1  2/300 (0.67%)  0/298 (0.00%)  2/303 (0.66%) 
Cataract  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Gastrointestinal disorders       
Colitis ischaemic  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Constipation  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Diarrhoea  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Diverticular hernia  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Diverticulum intestinal  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Duodenal ulcer haemorrhage  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Dyspepsia  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Enterocolitis  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Flatulence  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Gastric ulcer  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Gastric volvulus  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Gastritis  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Gastroduodenitis  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Gastrointestinal haemorrhage  1  1/300 (0.33%)  0/298 (0.00%)  2/303 (0.66%) 
Ileus  1  0/300 (0.00%)  2/298 (0.67%)  0/303 (0.00%) 
Inguinal hernia  1  0/300 (0.00%)  1/298 (0.34%)  1/303 (0.33%) 
Oesophagitis ulcerative  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Pancreatitis  1  0/300 (0.00%)  1/298 (0.34%)  2/303 (0.66%) 
Rectal ulcer  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Small intestinal obstruction  1  2/300 (0.67%)  0/298 (0.00%)  1/303 (0.33%) 
Upper gastrointestinal haemorrhage  1  1/300 (0.33%)  1/298 (0.34%)  0/303 (0.00%) 
Gastrointestinal angiectasia  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Obstructive pancreatitis  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Colitis  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
General disorders       
Chest pain  1  1/300 (0.33%)  1/298 (0.34%)  2/303 (0.66%) 
Death  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
General physical health deterioration  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Impaired healing  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Pyrexia  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Hepatobiliary disorders       
Bile duct stone  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Cholangitis  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Cholecystitis  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Cholelithiasis  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Infections and infestations       
Abdominal sepsis  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Bronchitis  1  0/300 (0.00%)  3/298 (1.01%)  0/303 (0.00%) 
Campylobacter infection  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Cellulitis  1  0/300 (0.00%)  1/298 (0.34%)  1/303 (0.33%) 
Cystitis  1  1/300 (0.33%)  0/298 (0.00%)  2/303 (0.66%) 
Device related infection  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Diverticulitis  1  2/300 (0.67%)  0/298 (0.00%)  1/303 (0.33%) 
Endocarditis  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Gastroenteritis  1  2/300 (0.67%)  1/298 (0.34%)  2/303 (0.66%) 
Infection  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Infectious pleural effusion  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Influenza  1  0/300 (0.00%)  2/298 (0.67%)  0/303 (0.00%) 
Perihepatic abscess  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Pneumonia  1  9/300 (3.00%)  11/298 (3.69%)  5/303 (1.65%) 
Pyelonephritis acute  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Sepsis  1  3/300 (1.00%)  3/298 (1.01%)  2/303 (0.66%) 
Septic shock  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Staphylococcal sepsis  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Upper respiratory tract infection  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Urinary tract infection  1  2/300 (0.67%)  3/298 (1.01%)  1/303 (0.33%) 
Viral upper respiratory tract infection  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Conjunctivitis  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Endophthalmitis  1  0/300 (0.00%)  2/298 (0.67%)  1/303 (0.33%) 
Injury, poisoning and procedural complications       
Accidental overdose  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Acetabulum fracture  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Ankle fracture  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Comminuted fracture  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Contusion  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Craniocerebral injury  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Dislocation of vertebra  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Fall  1  5/300 (1.67%)  2/298 (0.67%)  4/303 (1.32%) 
Femur fracture  1  1/300 (0.33%)  4/298 (1.34%)  0/303 (0.00%) 
Fibula fracture  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Forearm fracture  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Hip fracture  1  3/300 (1.00%)  3/298 (1.01%)  3/303 (0.99%) 
Humerus fracture  1  0/300 (0.00%)  2/298 (0.67%)  2/303 (0.66%) 
Internal injury  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Lower limb fracture  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Lumbar vertebral fracture  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Muscle rupture  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Pelvic fracture  1  1/300 (0.33%)  0/298 (0.00%)  1/303 (0.33%) 
Post procedural haemorrhage  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Radius fracture  1  2/300 (0.67%)  0/298 (0.00%)  0/303 (0.00%) 
Rib fracture  1  2/300 (0.67%)  2/298 (0.67%)  1/303 (0.33%) 
Road traffic accident  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Spinal compression fracture  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Spinal fracture  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Sternal fracture  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Subdural haematoma  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Upper limb fracture  1  0/300 (0.00%)  0/298 (0.00%)  2/303 (0.66%) 
Corneal abrasion  1  1/300 (0.33%)  1/298 (0.34%)  0/303 (0.00%) 
Facial bones fracture  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Hyphaema  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Cervical vertebral fracture  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Foreign body in eye  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Traumatic intracranial haemorrhage  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Investigations       
Blood pressure increased  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Heart rate irregular  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Myocardial necrosis marker increased  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Prostatic specific antigen increased  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Troponin increased  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Intraocular pressure increased  1  0/300 (0.00%)  16/298 (5.37%)  14/303 (4.62%) 
Metabolism and nutrition disorders       
Dehydration  1  2/300 (0.67%)  2/298 (0.67%)  2/303 (0.66%) 
Gout  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Hypoglycaemia  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Hypokalaemia  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Hyponatraemia  1  1/300 (0.33%)  2/298 (0.67%)  0/303 (0.00%) 
Iron deficiency  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Malnutrition  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1/300 (0.33%)  1/298 (0.34%)  0/303 (0.00%) 
Arthritis  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Haemarthrosis  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Intervertebral disc protrusion  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Neuropathic arthropathy  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Osteoarthritis  1  2/300 (0.67%)  3/298 (1.01%)  2/303 (0.66%) 
Rotator cuff syndrome  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Spinal column stenosis  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Spinal osteoarthritis  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Spinal pain  1  0/300 (0.00%)  2/298 (0.67%)  0/303 (0.00%) 
Back pain  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Benign neoplasm of ureter  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Bladder cancer  1  0/300 (0.00%)  1/298 (0.34%)  2/303 (0.66%) 
Breast cancer  1  2/300 (0.67%)  1/298 (0.34%)  0/303 (0.00%) 
Bronchial carcinoma  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Cholangiocarcinoma  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Endometrial cancer  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Lung adenocarcinoma  1  0/300 (0.00%)  3/298 (1.01%)  1/303 (0.33%) 
Lung cancer metastatic  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Lung neoplasm malignant  1  0/300 (0.00%)  0/298 (0.00%)  2/303 (0.66%) 
Malignant melanoma  1  2/300 (0.67%)  0/298 (0.00%)  0/303 (0.00%) 
Malignant melanoma stage IV  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Malignant pleural effusion  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Meningioma  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Myelodysplastic syndrome  1  1/300 (0.33%)  0/298 (0.00%)  1/303 (0.33%) 
Myxofibrosarcoma  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Neoplasm skin  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Neuroendocrine carcinoma  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Non−small cell lung cancer metastatic  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Oesophageal carcinoma  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Ovarian cancer  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Ovarian cancer metastatic  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Pancreatic carcinoma  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Plasma cell myeloma  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Prostate cancer  1  1/300 (0.33%)  2/298 (0.67%)  1/303 (0.33%) 
Prostate cancer metastatic  1  0/300 (0.00%)  0/298 (0.00%)  2/303 (0.66%) 
Skin cancer  1  1/300 (0.33%)  0/298 (0.00%)  1/303 (0.33%) 
Squamous cell carcinoma  1  0/300 (0.00%)  2/298 (0.67%)  0/303 (0.00%) 
Bladder neoplasm  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Lipoma  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Urethral cancer  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Nervous system disorders       
Amyotrophic lateral sclerosis  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Carotid artery stenosis  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Cerebral haematoma  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Cerebral infarction  1  0/300 (0.00%)  0/298 (0.00%)  2/303 (0.66%) 
Cerebral microangiopathy  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Cerebrovascular accident  1  3/300 (1.00%)  3/298 (1.01%)  1/303 (0.33%) 
Cervicogenic vertigo  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Dementia  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Dementia Alzheimer’s type  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Dizziness  1  1/300 (0.33%)  0/298 (0.00%)  1/303 (0.33%) 
Dural arteriovenous fistula  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Epilepsy  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Generalised tonic−clonic seizure  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Haemorrhagic stroke  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Headache  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Hemiparesis  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Ischaemic stroke  1  1/300 (0.33%)  1/298 (0.34%)  0/303 (0.00%) 
Lacunar infarction  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Lumbar radiculopathy  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Paraesthesia  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Presyncope  1  0/300 (0.00%)  2/298 (0.67%)  0/303 (0.00%) 
Seizure  1  1/300 (0.33%)  0/298 (0.00%)  1/303 (0.33%) 
Senile dementia  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Transient ischaemic attack  1  1/300 (0.33%)  4/298 (1.34%)  1/303 (0.33%) 
Vertigo CNS origin  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Syncope  1  2/300 (0.67%)  2/298 (0.67%)  2/303 (0.66%) 
Aphasia  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Cognitive disorder  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Embolic stroke  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Psychiatric disorders       
Mental status changes  1  1/300 (0.33%)  1/298 (0.34%)  2/303 (0.66%) 
Renal and urinary disorders       
Acute kidney injury  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Bladder cyst  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Chronic kidney disease  1  0/300 (0.00%)  2/298 (0.67%)  0/303 (0.00%) 
Dysuria  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Haematuria  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Hydronephrosis  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Nephrolithiasis  1  1/300 (0.33%)  3/298 (1.01%)  0/303 (0.00%) 
Oliguria  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Renal failure  1  0/300 (0.00%)  2/298 (0.67%)  1/303 (0.33%) 
Renal impairment  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Tubulointerstitial nephritis  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Urinary bladder polyp  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Urinary retention  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Reproductive system and breast disorders       
Postmenopausal haemorrhage  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Uterovaginal prolapse  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Respiratory, thoracic and mediastinal disorders       
Acute pulmonary oedema  1  0/300 (0.00%)  3/298 (1.01%)  0/303 (0.00%) 
Acute respiratory failure  1  0/300 (0.00%)  0/298 (0.00%)  2/303 (0.66%) 
Bronchial hyperreactivity  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Chronic obstructive pulmonary disease  1  0/300 (0.00%)  3/298 (1.01%)  5/303 (1.65%) 
Dyspnoea  1  1/300 (0.33%)  1/298 (0.34%)  1/303 (0.33%) 
Epiglottic cyst  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Epistaxis  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Haemoptysis  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Hypoxia  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Pleural effusion  1  0/300 (0.00%)  0/298 (0.00%)  2/303 (0.66%) 
Pneumonitis  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Pneumothorax  1  0/300 (0.00%)  1/298 (0.34%)  1/303 (0.33%) 
Pneumothorax spontaneous  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Pulmonary air leakage  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Pulmonary embolism  1  0/300 (0.00%)  2/298 (0.67%)  1/303 (0.33%) 
Skin and subcutaneous tissue disorders       
Skin ulcer  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Surgical and medical procedures       
Cardiac pacemaker battery replacement  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Vascular disorders       
Aortic stenosis  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Blood pressure inadequately controlled  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Deep vein thrombosis  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Haematoma  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Hypertension  1  1/300 (0.33%)  2/298 (0.67%)  0/303 (0.00%) 
Hypotension  1  1/300 (0.33%)  0/298 (0.00%)  2/303 (0.66%) 
May−Thurner syndrome  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Peripheral arterial occlusive disease  1  0/300 (0.00%)  0/298 (0.00%)  1/303 (0.33%) 
Peripheral embolism  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
Thrombophlebitis  1  0/300 (0.00%)  1/298 (0.34%)  0/303 (0.00%) 
Orthostatic hypotension  1  1/300 (0.33%)  0/298 (0.00%)  0/303 (0.00%) 
1
Term from vocabulary, MedDRA, version 20.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   221/300 (73.67%)   239/298 (80.20%)   232/303 (76.57%) 
Eye disorders       
Conjunctival haemorrhage  1  84/300 (28.00%)  111/298 (37.25%)  93/303 (30.69%) 
Eye pain  1  20/300 (6.67%)  39/298 (13.09%)  33/303 (10.89%) 
Vitreous floaters  1  16/300 (5.33%)  41/298 (13.76%)  25/303 (8.25%) 
Vitreous detachment  1  24/300 (8.00%)  22/298 (7.38%)  24/303 (7.92%) 
Dry eye  1  25/300 (8.33%)  23/298 (7.72%)  14/303 (4.62%) 
Cataract  1  12/300 (4.00%)  22/298 (7.38%)  15/303 (4.95%) 
Posterior capsule opacification  1  14/300 (4.67%)  21/298 (7.05%)  13/303 (4.29%) 
Retinal haemorrhage  1  20/300 (6.67%)  14/298 (4.70%)  17/303 (5.61%) 
Punctate keratitis  1  15/300 (5.00%)  16/298 (5.37%)  16/303 (5.28%) 
Gastrointestinal disorders       
Nausea  1  15/300 (5.00%)  10/298 (3.36%)  7/303 (2.31%) 
Infections and infestations       
Bronchitis  1  22/300 (7.33%)  29/298 (9.73%)  26/303 (8.58%) 
Urinary tract infection  1  25/300 (8.33%)  26/298 (8.72%)  21/303 (6.93%) 
Upper respiratory tract infection  1  17/300 (5.67%)  14/298 (4.70%)  11/303 (3.63%) 
Influenza  1  12/300 (4.00%)  14/298 (4.70%)  16/303 (5.28%) 
Nasopharyngitis  1  27/300 (9.00%)  45/298 (15.10%)  34/303 (11.22%) 
Injury, poisoning and procedural complications       
Fall  1  36/300 (12.00%)  29/298 (9.73%)  34/303 (11.22%) 
Investigations       
Intraocular pressure increased  1  9/300 (3.00%)  42/298 (14.09%)  27/303 (8.91%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  25/300 (8.33%)  20/298 (6.71%)  14/303 (4.62%) 
Arthralgia  1  11/300 (3.67%)  21/298 (7.05%)  15/303 (4.95%) 
Nervous system disorders       
Headache  1  7/300 (2.33%)  20/298 (6.71%)  13/303 (4.29%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  9/300 (3.00%)  16/298 (5.37%)  13/303 (4.29%) 
Vascular disorders       
Hypertension  1  14/300 (4.67%)  16/298 (5.37%)  13/303 (4.29%) 
1
Term from vocabulary, MedDRA, version 20.1
Indicates events were collected by systematic assessment
This study was terminated early by the Sponsor because the compound had demonstrated to lack of efficacy. Thus, not all participants in this study completed the full duration of treatment.
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 study being conducted under this agreement is part of the overall study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study, but only after the first publication or presentation that involves the overall study. The Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821 - 8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02247479     History of Changes
Other Study ID Numbers: GX29176
2014-000107-27 ( EudraCT Number )
First Submitted: July 15, 2014
First Posted: September 25, 2014
Results First Submitted: January 22, 2019
Results First Posted: April 23, 2019
Last Update Posted: April 23, 2019