Trial · NCT03525613
A Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration
NCT03525613, Phase 3, Completed, Apellis Pharmaceuticals, Inc.; results first posted 2023-07-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration. Trials, record NCT03525613. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03525613
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration
- NCT number
- NCT03525613
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 637 participants, actual
- Lead sponsor
- Apellis Pharmaceuticals, Inc.
- Conditions
- Geographic Atrophy
- Interventions
- APL-2, APL-2, Sham Procedure, Sham Procedure
- First posted
- 2018-05-15
- Last updated
- 2023-07-06
- Results first posted
- 2023-07-06
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Least Squares (LS) Mean Change From Baseline in Total Area of GA Lesions in the Study Eye at Month 12 | Baseline (screening) and Month 12 | The GA lesion area was measured by a quantified central reading center based on FAF images. LS mean was calculated using a mixed effect model for repeated measure (MMRM) model. Baseline was defined as the last available, non-missing observation prior to first study drug administration. |
| Secondary | LS Mean Change From Baseline in Total Area of GA Lesions in the Study Eye at Month 24 | Baseline (screening) and Month 24 | The GA lesion area was measured by a quantified central reading center based on FAF images. LS mean was calculated using a mixed effect model for repeated measure model. Baseline was defined as the last available, non-missing observation prior to first study drug administration. |
| Secondary | Mean Change in Total Area of GA Lesions in the Study Eye Through Month 24 | From Baseline (screening) through Month 24 | The mean change in GA lesion area through Month 24 was measured by assuming a piecewise linear trend in time with knots by FAF images at Months 6, 12, 18, and 24 and was calculated using a MMRM model. Baseline was defined as the last available, non-missing observation prior to first study drug administration. |
| Secondary | LS Mean Change From Baseline in Mean Threshold Sensitivity of All Points of the Study Eye at Month 24 | Baseline (screening) and Month 24 | Mean threshold sensitivity of all points was determined from the mesopic microperimetry as an assessment of the macular functional response. Microperimetry offers the option to test retinal light sensitivity while directly observing the fundus and allows for monitoring of macular function loss associated with GA progression. The microperimetry reading center overlaid the baseline FAF images with GA lesions traced by the imaging reading center and the corresponding macular integrity assessment microperimetry baseline scanning laser ophthalmoscope image and identified perilesional (within 500 microns outside the atrophy border), paralesional (beyond 500 microns outside the atrophy border), and extralesional (outside the atrophy border) loci on the microperimetry grid to determine the mean threshold sensitivity for these 3 areas. LS mean was calculated using a MMRM model. Baseline was defined as the last available, non-missing observation prior to first study drug administration. |
| Secondary | LS Mean Change From Baseline in Monocular Maximum Reading Speed of the Study Eye at Month 24 | Baseline (screening) and Month 24 | The maximum reading speed of the study eye was calculated per Minnesota Low-Vision Reading Test (MNREAD) or Radner Reading Charts user manuals, with no adjustment for reading inaccuracy. An additional step to cap resulting reading speed values at a maximum of 300 words per minute (wpm) was implemented. Maximum reading speed was calculated as the mean of the 3 highest non-zero reading speeds (or 2, or 1 value, as available), except when all wpm were calculated as 0 then the maximum reading speed was calculated as 0. LS mean was calculated using a MMRM model. Baseline was defined as the last available, non-missing observation prior to first study drug administration. |
| Secondary | LS Mean Change From Baseline in Mean Functional Reading Independence (FRI) Index Score at Month 24 | Baseline (screening) and Month 24 | The FRI was an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD subjects. It had 1 total index score. For each FRI Index reading activity performed in the past 7 days, subjects were asked about the extent to which they required assistance beyond eyeglasses/contact lenses, including the use of low-vision aids, adjustments in the activity, or help from another subject. Mean FRI Index scores ranged from 1 (unable to do independently) to 4 (totally independent), with higher scores indicating higher functional reading independence. A negative change from baseline indicated a decrease in the FRI; disease worsening. LS mean was calculated using a MMRM model. Baseline was defined as the last available, non-missing observation prior to first study drug administration. |
| Secondary | LS Mean Change From Baseline in Normal-Luminance Best-Corrected Visual Acuity (NL-BCVA) Score of the Study Eye at Month 24 | Baseline (screening) and Month 24 | The NL-BCVA was assessed by early treatment diabetic retinopathy study (ETDRS) chart prior to dilating the eyes at a starting distance of 4 meters and ranged from 0 (least score) to 100 (best score). If the 4-meter score was \>19 letters read correctly, the visual acuity score was the sum of total letters correctly read at 4 meters plus the addition of 30. If the 4-meter score was ≤19 letters read correctly, the visual acuity score was the sum of total letters read correctly at 4 meters and total letters read correctly at the 1-meter distance. If no letters were read correctly at either the 4-meter distance or the 1-meter distance, the visual acuity score was 0. A positive change in the value indicated improvement in visual acuity. LS mean was calculated using a MMRM model. Baseline was defined as the last available, non-missing observation prior to first study drug administration. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Least Squares (LS) Mean Change From Baseline in Total Area of GA Lesions in the Study Eye at Month 12 | Baseline (screening) and Month 12 | The modified intent-to-treat (mITT) analysis set included all subjects assigned to treatment who received at least 1 injection of pegcetacoplan or sham and had baseline and at least 1 post-baseline value of GA lesion area in the study eye as assessed by FAF. Subjects with a baseline and at least 1 post-baseline value of the outcome at a scheduled visit by Month 12 were included in the analysis. | mm^2 | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Change From Baseline in Total Area of GA Lesions in the Study Eye at Month 24 | Baseline (screening) and Month 24 | The mITT analysis set included all subjects assigned to treatment who received at least 1 injection of pegcetacoplan or sham and had baseline and at least 1 post-baseline value of GA lesion area in the study eye as assessed by FAF. Subjects with a baseline and at least 1 post-baseline value of the outcome at a scheduled visit by Month 24 were included in the analysis. | mm^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change in Total Area of GA Lesions in the Study Eye Through Month 24 | From Baseline (screening) through Month 24 | The mITT analysis set included all subjects assigned to treatment who received at least 1 injection of pegcetacoplan or sham and had baseline and at least 1 post-baseline value of GA lesion area in the study eye as assessed by FAF. | mm^2 | MEAN |
| SECONDARY | LS Mean Change From Baseline in Mean Threshold Sensitivity of All Points of the Study Eye at Month 24 | Baseline (screening) and Month 24 | The mITT analysis set included all subjects assigned to treatment who received at least 1 injection of pegcetacoplan or sham and had baseline and at least 1 post-baseline value of GA lesion area in the study eye as assessed by FAF. Subjects with a baseline and at least 1 post-baseline value of the outcome at a scheduled visit by Month 24 were included in the analysis. | decibels (dB) | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Change From Baseline in Monocular Maximum Reading Speed of the Study Eye at Month 24 | Baseline (screening) and Month 24 | The mITT analysis set included all subjects assigned to treatment who received at least 1 injection of pegcetacoplan or sham and had baseline and at least 1 post-baseline value of GA lesion area in the study eye as assessed by FAF. Subjects with a baseline and at least 1 post-baseline value of the outcome at a scheduled visit by Month 24 were included in the analysis. | wpm | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Change From Baseline in Mean Functional Reading Independence (FRI) Index Score at Month 24 | Baseline (screening) and Month 24 | The mITT analysis set included all subjects assigned to treatment who received at least 1 injection of pegcetacoplan or sham and had baseline and at least 1 post-baseline value of GA lesion area in the study eye as assessed by FAF. Subjects with a baseline and at least 1 post-baseline value of the outcome at a scheduled visit by Month 24 were included in the analysis. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Change From Baseline in Normal-Luminance Best-Corrected Visual Acuity (NL-BCVA) Score of the Study Eye at Month 24 | Baseline (screening) and Month 24 | The mITT analysis set included all subjects assigned to treatment who received at least 1 injection of pegcetacoplan or sham and had baseline and at least 1 post-baseline value of GA lesion area in the study eye as assessed by FAF. Subjects with a baseline and at least 1 post-baseline value of the outcome at a scheduled visit by Month 24 were included in the analysis. | ETDRS letters score | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Least Squares (LS) Mean Change From Baseline in Total Area of GA Lesions in the Study Eye at Month 12 | Pegcetacoplan Monthly | 1.5579 | Standard Error 0.08350 | mm^2 | |
| Least Squares (LS) Mean Change From Baseline in Total Area of GA Lesions in the Study Eye at Month 12 | Pegcetacoplan EOM | 1.6512 | Standard Error 0.08118 | mm^2 | |
| Least Squares (LS) Mean Change From Baseline in Total Area of GA Lesions in the Study Eye at Month 12 | Sham Pooled | 1.9692 | Standard Error 0.08218 | mm^2 | |
| LS Mean Change From Baseline in Total Area of GA Lesions in the Study Eye at Month 24 | Pegcetacoplan Monthly | 3.1237 | Standard Error 0.14327 | mm^2 | |
| LS Mean Change From Baseline in Total Area of GA Lesions in the Study Eye at Month 24 | Pegcetacoplan EOM | 3.2826 | Standard Error 0.13238 | mm^2 | |
| LS Mean Change From Baseline in Total Area of GA Lesions in the Study Eye at Month 24 | Sham Pooled | 4.0252 | Standard Error 0.14642 | mm^2 | |
| Mean Change in Total Area of GA Lesions in the Study Eye Through Month 24 | Pegcetacoplan Monthly | From Baseline to Month 6 | 0.7604 | Standard Error 0.04629 | mm^2 |
| Mean Change in Total Area of GA Lesions in the Study Eye Through Month 24 | Pegcetacoplan EOM | From Baseline to Month 6 | 0.8220 | Standard Error 0.04346 | mm^2 |
| Mean Change in Total Area of GA Lesions in the Study Eye Through Month 24 | Sham Pooled | From Baseline to Month 6 | 0.9838 | Standard Error 0.04666 | mm^2 |
| Mean Change in Total Area of GA Lesions in the Study Eye Through Month 24 | Pegcetacoplan Monthly | From Month 6 to Month 12 | 0.7848 | Standard Error 0.05958 | mm^2 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pegcetacoplan Monthly | 213 | |
| Overall Study | STARTED | Pegcetacoplan EOM | 212 | |
| Overall Study | STARTED | Sham Monthly | 106 | |
| Overall Study | STARTED | Sham EOM | 106 | |
| Overall Study | COMPLETED | Pegcetacoplan Monthly | 144 | |
| Overall Study | COMPLETED | Pegcetacoplan EOM | 169 | |
| Overall Study | COMPLETED | Sham Monthly | 76 | |
| Overall Study | COMPLETED | Sham EOM | 82 | |
| Overall Study | NOT COMPLETED | Pegcetacoplan Monthly | 69 | |
| Overall Study | NOT COMPLETED | Pegcetacoplan EOM | 43 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events2,016
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 | Pegcetacoplan Monthly: Ocular Study Eye | 22 | 213 | 39 |
| other | Conjunctival haemorrhage | Eye disorders | Pegcetacoplan EOM: Ocular Study Eye | 19 | 212 | 25 |
| other | Conjunctival haemorrhage | Eye disorders | Sham Pooled: Ocular Study Eye | 10 | 211 | 10 |
| other | Conjunctival haemorrhage | Eye disorders | Pegcetacoplan Monthly: Ocular Fellow Eye | 2 | 213 | 2 |
| other | Conjunctival haemorrhage | Eye disorders | Pegcetacoplan EOM: Ocular Fellow Eye | 3 | 212 | 3 |
| other | Conjunctival haemorrhage | Eye disorders | Sham Pooled: Ocular Fellow Eye | 3 | 211 | 4 |
| other | Conjunctival haemorrhage | Eye disorders | Pegcetacoplan Monthly: Non-ocular | 0 | 213 | 0 |
| other | Conjunctival haemorrhage | Eye disorders | Pegcetacoplan EOM: Non-ocular | 0 | 212 | 0 |
| other | Conjunctival haemorrhage | Eye disorders | Sham Pooled: Non-ocular | 0 | 211 | 0 |
| other | Visual acuity reduced | Eye disorders | Pegcetacoplan Monthly: Ocular Study Eye | 17 | 213 | 21 |
1 to 10 of 2,016Source ClinicalTrials.gov
See all 2,016 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pegcetacoplan Monthly: Ocular Study Eye | 0 | 213 |
| Total, all-cause mortality | Pegcetacoplan EOM: Ocular Study Eye | 0 | 212 |
| Total, all-cause mortality | Sham Pooled: Ocular Study Eye | 0 | 211 |
| Total, all-cause mortality | Pegcetacoplan Monthly: Ocular Fellow Eye | 0 | 213 |
| Total, all-cause mortality | Pegcetacoplan EOM: Ocular Fellow Eye | 0 | 212 |
| Total, all-cause mortality | Sham Pooled: Ocular Fellow Eye | 0 | 211 |
| Total, all-cause mortality | Pegcetacoplan Monthly: Non-ocular | 20 | 213 |
| Total, all-cause mortality | Pegcetacoplan EOM: Non-ocular | 9 | 212 |
| Total, all-cause mortality | Sham Pooled: Non-ocular | 8 | 211 |
| Total, other adverse events | Pegcetacoplan Monthly: Ocular Study Eye | 100 | 213 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers6
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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03525613
GET https://conductscience.org/api/trials/v1/NCT03525613/results?page=2