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NCT01521559 · ClinicalTrials.gov registry record · Phase 3

Study to Assess the Clinical Efficacy and Safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in Patients With Branch Retinal Vein Occlusion (BRVO)

A Phase 3 study of Branch Retinal Vein Occlusion, sponsored by Regeneron Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
183
Enrollment target
20
Study locations

NCT01521559: Completed Phase 3 study of Branch Retinal Vein Occlusion, sponsored by Regeneron Pharmaceuticals.

NCT01521559 is a Phase 3 study of Branch Retinal Vein Occlusion that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 183 participants, below the 2,011-participant average among 3 other Branch Retinal Vein Occlusion trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01521559, a Phase 3 study of Branch Retinal Vein Occlusion, has completed, sponsored by Regeneron Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
183 participants
Enrollment target
20
Study locations

Study Summary

This is a phase III, double-masked, randomized, active-controlled, parallel-group, 52-week study to assess the efficacy and safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) compared to laser treatment in patients with macular edema secondary to BRVO.

Primary Outcome

Best corrected visual acuity (BCVA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at every visit from baseline through week 24. Last observation carried forward (LOCF) method was used to impute missing data.

Conditions Studied

Branch Retinal Vein Occlusion

Interventions

  • PROCEDURE Macular Laser Photocoagulation
  • DRUG Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)

Study Locations (20)

Florida

  • - Fort Myers
  • - Miami
  • - Plantation
  • - Stuart
  • - Tampa
  • - Winter Haven

California

  • - Beverly Hills
  • - La Jolla
  • - Mountain View
  • - Palm Desert
  • - Sacramento

Arizona

  • - Phoenix
  • - Tucson

Maryland

  • - Baltimore (2 Locations)
  • - Hagerstown

Colorado

  • - Colorado Springs

Georgia

  • - Augusta

Illinois

  • - Chicago

Massachusetts

  • - Boston (2 Locations)

Trial Details

FieldValue
Enrollment Target 183 participants
Start Date 2012-04
Est. Completion 2014-03
Phase Phase 3
Regeneron Pharmaceuticals

280 total trials

What the finished NCT01521559 record still lists

NCT01521559 is an interventional study that assigns participants to a tested intervention. The registered 183 participants enrollment target is mid-sized for trials with a published cap, below the 2,011-participant average among 3 other Branch Retinal Vein Occlusion trials with a reported enrollment target (91% lower).

The record links to 1 condition, with Branch Retinal Vein Occlusion appearing as the primary indexed condition, and to 2 interventions - of which Macular Laser Photocoagulation is the first listed.

NCT01521559 names 20 study sites across 9 states, led by Florida, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT01521559 about?

NCT01521559 is a clinical study titled "Study to Assess the Clinical Efficacy and Safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in Patients With Branch Retinal Vein Occlusion (BRVO)". This is a phase III, double-masked, randomized, active-controlled, parallel-group, 52-week study to assess the efficacy and safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) compared to laser treatment in patients with macular edema secondary to BRVO.

What is the current status of trial NCT01521559?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 183 participants. The study started on 2012-04. Estimated completion is 2014-03.

What conditions does trial NCT01521559 study?

This clinical trial studies the following conditions: Branch Retinal Vein Occlusion.

What interventions are being tested in trial NCT01521559?

The interventions under investigation include: Macular Laser Photocoagulation (PROCEDURE), Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) (DRUG).

Who is sponsoring clinical trial NCT01521559?

This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01521559 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT01521559, the US trial registry maintained by the National Library of Medicine. NCT01521559 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.