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NCT03525600 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Geographic Atrophy, sponsored by Apellis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 621
- Enrollment target
- 20
- Study locations
NCT03525600: Completed Phase 3 study of Geographic Atrophy, sponsored by Apellis Pharmaceuticals.
NCT03525600 is a Phase 3 study of Geographic Atrophy that has completed, run by Apellis Pharmaceuticals. The registered enrollment target is 621 participants, above the 199-participant average among 27 other Geographic Atrophy trials with a reported enrollment target (212% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03525600, a Phase 3 study of Geographic Atrophy, has completed, sponsored by Apellis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 621 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a 24-month, Phase III, multicenter, randomized, double-masked, sham-injection controlled study to assess the efficacy and safety of multiple IVT injections of APL-2 in subjects with GA secondary to AMD.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Sham Procedure
- DRUG APL-2
Study Locations (20)
California
- Retina Institute of California dba Acuity Eye Grp - Arcadia
- California Retina Consultants - Bakersfield
- Retina Vitreous Associates Medical Group - Beverly Hills
- The Retina Partners - Encino
- The Gavin Herbert Eye Institute/UC Irvine - Irvine
- Northern California Retina Vitreous Associates - Mountain View
- Retina Institute of California Medical Group - Palm Desert
- Byers Eye Institute at Standford, Stanford School of Medicine - Palo Alto
- Retina Consultants San Diego - Poway
- Retina Consultants of Southern California - Redlands
- California Retina Consultants - Santa Barbara
- Bay Area Retina Associates - Walnut Creek
Connecticut
- Danbury Eye Physicians & Surgeons, P.C. - Danbury - Danbury
- New England Retina Associates - Hamden
- Retina Group of New England,PC - Waterford
Florida
- Florida Eye Microsurgical Institute, Inc. - Boynton Beach
- Pinnacle Research Institute - Fort Lauderdale
- Retina Health Center - Fort Myers
Arizona
- Retinal Research Institute - Phoenix
- Associated Retina Consultants, Ltd - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 621 participants |
| Start Date | 2018-08-31 |
| Est. Completion | 2022-06-20 |
| Phase | Phase 3 |
What the finished NCT03525600 record still lists
NCT03525600 is an interventional study that assigns participants to a tested intervention. The registered 621 participants enrollment target is mid-sized for trials with a published cap, above the 199-participant average among 27 other Geographic Atrophy trials with a reported enrollment target (212% higher).
The record links to 1 condition, with Geographic Atrophy appearing as the primary indexed condition, and to 2 interventions - of which Sham Procedure is the first listed.
NCT03525600 names 20 study sites across 4 states, led by California, Connecticut, Florida.
Frequently Asked Questions
What is clinical trial NCT03525600 about?
NCT03525600 is a clinical study titled "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". This is a 24-month, Phase III, multicenter, randomized, double-masked, sham-injection controlled study to assess the efficacy and safety of multiple IVT injections of APL-2 in subjects with GA secondary to AMD.
What is the current status of trial NCT03525600?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 621 participants. The study started on 2018-08-31. Estimated completion is 2022-06-20.
What conditions does trial NCT03525600 study?
This clinical trial studies the following conditions: Geographic Atrophy.
What interventions are being tested in trial NCT03525600?
The interventions under investigation include: Sham Procedure (OTHER), APL-2 (DRUG).
Who is sponsoring clinical trial NCT03525600?
This trial is sponsored by Apellis Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03525600 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Geographic Atrophy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03525600's enrollment target sits among peer trials
621 3rd of 27 higher than 25 of 27 other Geographic Atrophy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Geographic Atrophy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of Vonaprument (Formerly ANX007) in Participants With Geographic Atrophy (GA)
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-
Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy
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Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
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High Resolution Retinal Imaging
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-
A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
RECRUITING · Phase 2
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