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NCT04429503 · ClinicalTrials.gov registry record · Phase 2
Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease
A Phase 2 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 660
- Enrollment target
NCT04429503: Completed Phase 2 study, sponsored by Regeneron Pharmaceuticals.
NCT04429503 is a Phase 2 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 660 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (396% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04429503, a Phase 2 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 660 participants
- Enrollment target
Study Summary
The primary objective of the study is to determine if treatment with high-dose aflibercept (HD) at intervals of 12 or 16 weeks provides non-inferior best corrected visual acuity (BCVA) compared to aflibercept dosed every 8 weeks. The secondary objectives of the study are as follows: * To determine the effect of HD vs. aflibercept on anatomic and other visual measures of response * To evaluate the safety, immunogenicity, and pharmacokinetics (PK) of aflibercept
Primary Outcome
Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best).
Interventions
- DRUG aflibercept
- DRUG High-dose aflibercept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 660 participants |
| Start Date | 2020-06-29 |
| Est. Completion | 2024-06-18 |
| Phase | Phase 2 |
What the finished NCT04429503 record still lists
NCT04429503 is an interventional study that assigns participants to a tested intervention. The registered 660 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (396% higher).
The record links to 0 conditions, and to 2 interventions - of which aflibercept is the first listed.
NCT04429503 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04429503 about?
NCT04429503 is a clinical study titled "Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease". The primary objective of the study is to determine if treatment with high-dose aflibercept (HD) at intervals of 12 or 16 weeks provides non-inferior best corrected visual acuity (BCVA) compared to aflibercept dosed every 8 weeks. The secondary objectives of the study are as follows: * To determine...
What is the current status of trial NCT04429503?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 660 participants. The study started on 2020-06-29. Estimated completion is 2024-06-18.
What interventions are being tested in trial NCT04429503?
The interventions under investigation include: aflibercept (DRUG), High-dose aflibercept (DRUG).
Who is sponsoring clinical trial NCT04429503?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04429503's enrollment target sits among peer trials
660 49th of 2000 higher than 1,951 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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