Trial · NCT02247531
A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
NCT02247531, Phase 3, Terminated, Hoffmann-La Roche; results first posted 2019-03-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration. Trials, record NCT02247531. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02247531
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
- NCT number
- NCT02247531
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 975 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Geographic Atrophy
- Interventions
- Lampalizumab, Sham Comparator
- First posted
- 2014-09-25
- Last updated
- 2019-10-15
- Other registries' IDs
- eudract:2014-000106-35
- Results first posted
- 2019-03-14
- Limitations and caveats
- This study was terminated early by the Sponsor because the compound had demonstrated lack of efficacy. Thus, not all participants in this study completed the full duration of treatment.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Geographic Atropy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48 | Baseline, Week 48 | 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). |
| Primary | Change From Baseline in GA Area in Complement Factor I (CFI) Positive and Negative Participants at Week 48 | Baseline, Week 48 | 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). |
| Secondary | Change From Baseline in Number of Absolute Scotomatous Points Assessed by Mesopic Microperimetry at Week 48 | Baseline, Week 48 | 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. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. A positive change from baseline indicates an increase in the number of absolute scotomatous points (more lack of retinal sensitivity); disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study. |
| Secondary | Change From Baseline in Macular Sensitivity as Assessed by Mesopic Microperimetry at Week 48 | Baseline, Week 48 | 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. Data were collected up to Week 48 instead of Week 96, due to early termination of the study. |
| Secondary | Change From Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Week 48 | Baseline, Week 48 | 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). A decrease in the VA score indicates a worsening in visual acuity. BCVA score testing was performed prior to dilating the eyes. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. 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. |
| Secondary | Percentage of Participants With Less Than 15 Letters Loss From Baseline in BCVA Score at Week 48 | Week 48 | Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 meters (m). Data were collected up to Week 48 instead of Week 96, due to early termination of the study. |
| Secondary | Change From Baseline in Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under Low Luminance Conditions at Week 48 | Baseline, Week 48 | The low luminance visual acuity 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. A negative change from baseline indicates a decrease in the visual acuity; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study. |
| Secondary | Percentage of Participants With Less Than 15 Letters Loss From Baseline in LLVA Score at Week 48 | Week 48 | Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 m. Data were collected up to Week 48 instead of Week 96, due to early termination of the study. |
| Secondary | Change From Baseline in Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test (MNRead) Charts or Radner Reading Charts at Week 48 | Baseline, Week 48 | 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. Data were collected up to Week 48 instead of Week 96, due to early termination of the study. |
| Secondary | Change From Baseline in Monocular Maximum Reading Speed as Assessed by MNRead Charts or Radner Reading Charts at Week 48 | Baseline, Week 48 | 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. 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Geographic Atropy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48 | Baseline, Week 48 | Intent-to-treat (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). | millimeter square (mm^2) | MEAN |
| SECONDARY | Change From Baseline in Number of Absolute Scotomatous Points Assessed by Mesopic Microperimetry at Week 48 | Baseline, Week 48 | 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. | number of absolute scotomatous points | MEAN |
| SECONDARY | Change From Baseline in Macular Sensitivity as Assessed by Mesopic Microperimetry at Week 48 | Baseline, Week 48 | 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. | decibel (dB) | MEAN |
| SECONDARY | Change From Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Week 48 | Baseline, Week 48 | ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis. | letters | MEAN |
| SECONDARY | Percentage of Participants With Less Than 15 Letters Loss From Baseline in BCVA Score at Week 48 | Week 48 | ITT population included all the participants who were randomized to the study. Reported here is the number of participants for whom data were collected. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under Low Luminance Conditions at Week 48 | Baseline, Week 48 | ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis. | letters | MEAN |
| SECONDARY | Percentage of Participants With Less Than 15 Letters Loss From Baseline in LLVA Score at Week 48 | Week 48 | ITT population included all the participants who were randomized to the study. Reported here is the number of participants for whom data were collected. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test (MNRead) Charts or Radner Reading Charts at Week 48 | Baseline, Week 48 | ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis. | words per minute (wpm) | MEAN |
| SECONDARY | Change From Baseline in Monocular Maximum Reading Speed as Assessed by MNRead Charts or Radner Reading Charts at Week 48 | Baseline, Week 48 | ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis. | wpm | MEAN |
| SECONDARY | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item (NEI VFQ-25) Version Composite Score at Week 48 | Baseline, Week 48 | ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis. | score on a scale | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Geographic Atropy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48 | Sham Comparator | 1.932 | Standard Error 0.056 | millimeter square (mm^2) | |
| Change From Baseline in Geographic Atropy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48 | Lampalizumab Q4W | 2.089 | Standard Error 0.056 | millimeter square (mm^2) | |
| Change From Baseline in Geographic Atropy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48 | Lampalizumab Q6W | 2.019 | Standard Error 0.056 | millimeter square (mm^2) | |
| Change From Baseline in Number of Absolute Scotomatous Points Assessed by Mesopic Microperimetry at Week 48 | Sham Comparator | 5.4 | Standard Error 1.6 | number of absolute scotomatous points | |
| Change From Baseline in Number of Absolute Scotomatous Points Assessed by Mesopic Microperimetry at Week 48 | Lampalizumab Q4W | 5.0 | Standard Error 1.5 | number of absolute scotomatous points | |
| Change From Baseline in Number of Absolute Scotomatous Points Assessed by Mesopic Microperimetry at Week 48 | Lampalizumab Q6W | 6.7 | Standard Error 1.5 | number of absolute scotomatous points | |
| Change From Baseline in Macular Sensitivity as Assessed by Mesopic Microperimetry at Week 48 | Sham Comparator | -0.99 | Standard Error 0.36 | decibel (dB) | |
| Change From Baseline in Macular Sensitivity as Assessed by Mesopic Microperimetry at Week 48 | Lampalizumab Q4W | -0.89 | Standard Error 0.34 | decibel (dB) | |
| Change From Baseline in Macular Sensitivity as Assessed by Mesopic Microperimetry at Week 48 | Lampalizumab Q6W | -1.25 | Standard Error 0.35 | decibel (dB) | |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Week 48 | Sham Comparator | -5.3 | Standard Error 0.7 | letters |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sham Comparator | 321 | |
| Overall Study | STARTED | Lampalizumab Q4W | 330 | |
| Overall Study | STARTED | Lampalizumab Q6W | 324 | |
| Overall Study | COMPLETED | Sham Comparator | 215 | |
| Overall Study | COMPLETED | Lampalizumab Q4W | 205 | |
| Overall Study | COMPLETED | Lampalizumab Q6W | 214 | |
| Overall Study | NOT COMPLETED | Sham Comparator | 106 | |
| Overall Study | NOT COMPLETED | Lampalizumab Q4W | 125 | |
| Overall Study | NOT COMPLETED | Lampalizumab Q6W | 110 |
Source ClinicalTrials.gov
Adverse events843
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Conjunctival haemorrhage | Eye disorders | Sham Comparator | 84 | 318 | |
| other | Conjunctival haemorrhage | Eye disorders | Lampalizumab Q4W | 112 | 329 | |
| other | Conjunctival haemorrhage | Eye disorders | Lampalizumab Q6W | 97 | 323 | |
| other | Eye pain | Eye disorders | Sham Comparator | 30 | 318 | |
| other | Eye pain | Eye disorders | Lampalizumab Q4W | 55 | 329 | |
| other | Eye pain | Eye disorders | Lampalizumab Q6W | 36 | 323 | |
| other | Vitreous detachment | Eye disorders | Sham Comparator | 24 | 318 | |
| other | Vitreous detachment | Eye disorders | Lampalizumab Q4W | 37 | 329 | |
| other | Vitreous detachment | Eye disorders | Lampalizumab Q6W | 31 | 323 | |
| other | Cataract | Eye disorders | Sham Comparator | 25 | 318 |
1 to 10 of 843Source ClinicalTrials.gov
See all 843 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sham Comparator | 9 | 318 |
| Total, all-cause mortality | Lampalizumab Q4W | 10 | 329 |
| Total, all-cause mortality | Lampalizumab Q6W | 7 | 323 |
| Total, other adverse events | Sham Comparator | 227 | 318 |
| Total, other adverse events | Lampalizumab Q4W | 268 | 329 |
| Total, other adverse events | Lampalizumab Q6W | 253 | 323 |
| Total, serious adverse events | Sham Comparator | 99 | 318 |
| Total, serious adverse events | Lampalizumab Q4W | 113 | 329 |
| Total, serious adverse events | Lampalizumab Q6W | 111 | 323 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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