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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 is a Phase 3 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 466 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01363440
The ClinicalTrials.gov registry entry for NCT01363440 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 466 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 Macular Laser Photocoagulation is the first listed.
NCT01363440 reports 0 study locations.
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.
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