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NCT03525613 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Apellis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 637
- Enrollment target
NCT03525613: Completed Phase 3 study, sponsored by Apellis Pharmaceuticals.
NCT03525613 is a Phase 3 study that has completed, run by Apellis Pharmaceuticals. The registered enrollment target is 637 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03525613, a Phase 3 study, has completed, sponsored by Apellis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 637 participants
- Enrollment target
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.
Interventions
- OTHER Sham Procedure
- DRUG APL-2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 637 participants |
| Start Date | 2018-08-31 |
| Est. Completion | 2022-06-28 |
| Phase | Phase 3 |
What the finished NCT03525613 record still lists
NCT03525613 is an interventional study that assigns participants to a tested intervention. The registered 637 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham Procedure is the first listed.
NCT03525613 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03525613 about?
NCT03525613 is a clinical study titled "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". 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 NCT03525613?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 637 participants. The study started on 2018-08-31. Estimated completion is 2022-06-28.
What interventions are being tested in trial NCT03525613?
The interventions under investigation include: Sham Procedure (OTHER), APL-2 (DRUG).
Who is sponsoring clinical trial NCT03525613?
This trial is sponsored by Apellis Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03525613's enrollment target sits among peer trials
637 579th of 2000 higher than 1,422 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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