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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 is a Phase 2 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 660 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04429503
The ClinicalTrials.gov registry entry for NCT04429503 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 660 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which aflibercept is the first listed.
NCT04429503 reports 0 study locations.
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.
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