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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.

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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

FieldValue
Enrollment Target 466 participants
Start Date 2011-05
Est. Completion 2014-11
Phase Phase 3

Sponsor

Regeneron Pharmaceuticals

280 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.