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NCT01363440 · ClinicalTrials.gov registry record · Phase 3
Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Patients With Diabetic Macular Edema
A Phase 3 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 466
- Enrollment target
NCT01363440: Completed Phase 3 study, sponsored by Regeneron Pharmaceuticals.
NCT01363440 is a Phase 3 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 466 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01363440, a Phase 3 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 466 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the efficacy of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) on the best corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in patients with diabetic macular edema (DME) with central involvement.
Primary Outcome
Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye were included; a higher score represents better functioning.
Interventions
- PROCEDURE Macular Laser Photocoagulation
- DRUG Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 466 participants |
| Start Date | 2011-05 |
| Est. Completion | 2014-11 |
| Phase | Phase 3 |
What the finished NCT01363440 record still lists
NCT01363440 is an interventional study that assigns participants to a tested intervention. The registered 466 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 (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Macular Laser Photocoagulation is the first listed.
NCT01363440 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01363440 about?
NCT01363440 is a clinical study titled "Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Patients With Diabetic Macular Edema". The purpose of this study is to determine the efficacy of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) on the best corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in patients with diabetic macular edema (DME) with central involv...
What is the current status of trial NCT01363440?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 466 participants. The study started on 2011-05. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01363440?
The interventions under investigation include: Macular Laser Photocoagulation (PROCEDURE), Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) (DRUG).
Who is sponsoring clinical trial NCT01363440?
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 NCT01363440's enrollment target sits among peer trials
466 816th of 2000 higher than 1,182 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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