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NCT04757636 · ClinicalTrials.gov registry record · Phase 3
OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (nAMD)
A Phase 3 study, sponsored by Opthea Limited.
- Terminated
- Registry status
- Phase 3
- Development phase
- 998
- Enrollment target
NCT04757636: Clinical Trial Phase 3 study, sponsored by Opthea Limited.
NCT04757636 is a Phase 3 study that was terminated before completion, run by Opthea Limited. The registered enrollment target is 998 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04757636, a Phase 3 study, was terminated before completion, sponsored by Opthea Limited.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 998 participants
- Enrollment target
Study Summary
A 2-year phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.
Primary Outcome
To determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular age-related macular degeneration (nAMD), in terms of change in ETDRS BCVA letter score in the study eye from Baseline to Week 52. The primary analysis presented used mixed model for repeated measures in the overall population. (A positive outcome measure means an improvement in ETDRS BCVA letter score from baseline; a negative outcome me
Interventions
- PROCEDURE Sham
- BIOLOGICAL 2.0 mg OPT-302
- BIOLOGICAL 2.0 aflibercept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 998 participants |
| Start Date | 2021-03-12 |
| Est. Completion | 2025-03-31 |
| Phase | Phase 3 |
Why NCT04757636 stopped before completion
NCT04757636 is an interventional study that assigns participants to a tested intervention. The registered 998 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% higher).
The record links to 0 conditions, and to 3 interventions - of which Sham is the first listed.
NCT04757636 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04757636 about?
NCT04757636 is a clinical study titled "OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (nAMD)". A 2-year phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.
What is the current status of trial NCT04757636?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 998 participants. The study started on 2021-03-12. Estimated completion is 2025-03-31.
What interventions are being tested in trial NCT04757636?
The interventions under investigation include: Sham (PROCEDURE), 2.0 mg OPT-302 (BIOLOGICAL), 2.0 aflibercept (BIOLOGICAL).
Who is sponsoring clinical trial NCT04757636?
This trial is sponsored by Opthea Limited, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04757636's enrollment target sits among peer trials
998 312th of 2000 higher than 1,689 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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