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NCT00789477 · ClinicalTrials.gov registry record · Phase 2
DME And VEGF Trap-Eye [Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)] INvestigation of Clinical Impact
A Phase 2 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 221
- Enrollment target
NCT00789477: Completed Phase 2 study, sponsored by Regeneron Pharmaceuticals.
NCT00789477 is a Phase 2 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 221 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00789477, a Phase 2 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 221 participants
- Enrollment target
Study Summary
This is a Phase 2, doubled-masked, randomized study of the efficacy and safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in subjects with diabetic macular edema (DME). Approximately 200 subjects will be randomized in the US, Canada, Australia and EU.
Primary Outcome
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Measurements were taken at every study visit. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).
Interventions
- DRUG Intravitreal Aflibercept Injection
- PROCEDURE Laser Photocoagulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 221 participants |
| Start Date | 2008-12 |
| Est. Completion | 2010-09 |
| Phase | Phase 2 |
What the finished NCT00789477 record still lists
NCT00789477 is an interventional study that assigns participants to a tested intervention. The registered 221 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 (66% higher).
The record links to 0 conditions, and to 2 interventions - of which Intravitreal Aflibercept Injection is the first listed.
NCT00789477 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00789477 about?
NCT00789477 is a clinical study titled "DME And VEGF Trap-Eye [Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)] INvestigation of Clinical Impact". This is a Phase 2, doubled-masked, randomized study of the efficacy and safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in subjects with diabetic macular edema (DME). Approximately 200 subjects will be randomized in the US, Canada, Australia and EU.
What is the current status of trial NCT00789477?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 221 participants. The study started on 2008-12. Estimated completion is 2010-09.
What interventions are being tested in trial NCT00789477?
The interventions under investigation include: Intravitreal Aflibercept Injection (DRUG), Laser Photocoagulation (PROCEDURE).
Who is sponsoring clinical trial NCT00789477?
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 NCT00789477's enrollment target sits among peer trials
221 275th of 2000 higher than 1,726 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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