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

November 5, 2014 updated by: Regeneron Pharmaceuticals

A Double-Masked, Randomized, Active-Controlled Study of the Efficacy, Safety, and Tolerability of Intravitreal Administration of VEGF Trap-Eye (Intravitreal Aflibercept Injection [IAI]) in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

183

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
      • Victoria, British Columbia, Canada
    • Ontario
      • Mississauga, Ontario, Canada
      • Toronto, Ontario, Canada
  • Japan
      • Fukushima, Japan
      • Kyoto, Japan
      • Osaka, Japan
    • Chiba
      • Urayasu-shi, Chiba, Japan
    • Hyogo
      • Amagasaki, Hyogo, Japan
    • Kagoshima
      • Kagoshima-shi, Kagoshima, Japan
    • Shizuoka
      • Hamamatsu-shi, Shizuoka, Japan
  • United States
    • Arizona
      • Phoenix, Arizona, United States
      • Tucson, Arizona, United States
    • California
      • Beverly Hills, California, United States
      • La Jolla, California, United States
      • Mountain View, California, United States
      • Palm Desert, California, United States
      • Sacramento, California, United States
    • Colorado
      • Colorado Springs, Colorado, United States
    • Florida
      • Fort Myers, Florida, United States
      • Miami, Florida, United States
      • Plantation, Florida, United States
      • Stuart, Florida, United States
      • Tampa, Florida, United States
      • Winter Haven, Florida, United States
    • Georgia
      • Augusta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
    • Maryland
      • Baltimore (2 locations), Maryland, United States
      • Hagerstown, Maryland, United States
    • Massachusetts
      • Boston (2 locations), Massachusetts, United States
    • Michigan
      • Grand Rapids, Michigan, United States
      • Jackson, Michigan, United States
      • Southfield, Michigan, United States
    • Missouri
      • Florissant, Missouri, United States
    • Nebraska
      • Lincoln, Nebraska, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Jersey
      • Teaneck, New Jersey, United States
    • New York
      • Orchard Park, New York, United States
      • Syracuse, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Kingston, Pennsylvania, United States
      • West Mifflin, Pennsylvania, United States
    • South Carolina
      • Florence, South Carolina, United States
      • Ladson, South Carolina, United States
      • West Columbia, South Carolina, United States
    • South Dakota
      • Rapid City, South Dakota, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Abilene, Texas, United States
      • Ft. Worth, Texas, United States
      • Harlingen, Texas, United States
      • Houston, Texas, United States
      • San Antonio, Texas, United States
    • Washington
      • Seattle, Washington, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

The following inclusion criteria include, but are not limited to:

  1. Adults ≥ 18 years of age with foveal center-involved macular edema (ME) secondary to BRVO diagnosed within 12 months before the screening visit
  2. ETDRS BCVA: letter score of 73 to 24 (20/40 to 20/320) in the study eye at screening and at day 1
  3. Provide signed informed consent

Exclusion Criteria:

The following exclusion criteria include, but are not limited to:

  1. Current bilateral manifestation of BRVO
  2. Uncontrolled glaucoma defined as ≥ 25 mmHg on optimal medical regimen, or previous filtration surgery in either the study eye or the fellow eye
  3. Insufficient clearing of macular hemorrhage that would prevent the patient from receiving laser treatment safely on day 1 (patients that meet this criterion may be rescreened once the macular hemorrhage resolves)
  4. Uncontrolled diabetes mellitus (DM)
  5. Previous use of intraocular corticosteroids or anti-angiogenic drugs in the study eye
  6. Use of periocular corticosteroids in the study eye within 3 months before day 1
  7. Use of intraocular or periocular corticosteroids or anti-angiogenic drugs in the fellow eye within 3 months before day 1
  8. Previous administration of systemic anti-angiogenic medications
  9. Panretinal scatter photocoagulation, sector laser photocoagulation, or macular grid photocoagulation in the study eye

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Macular Laser Photocoagulation Treatment (Control)
Participants will receive macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants will receive treatment with Intravitreal Aflibercept Injection (IAI) starting at week 24 if they met rescue criteria. Treatment with IAI once initiated was 3 initial monthly doses followed by Q8 week dosing.
Procedure: Macular Laser Photocoagulation
Experimental: Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
Participants will receive 2 milligrams (mg) Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24 followed by injections every 8 weeks (2Q8) through week 48. Participants in this group may receive laser rescue at week 36.
Drug: Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF
Time Frame: Baseline to week 24
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.
Baseline to week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 24 in BCVA Score - LOCF
Time Frame: Baseline to Week 24
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.
Baseline to Week 24
Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF
Time Frame: Baseline to week 24
CRT was evaluated at every visit from baseline through week 24 using spectral domain Optical Coherence Tomography (OCT).
Baseline to week 24
Change From Baseline in the National Eye Institute Visual Function Questionnaire - 25 (NEI VFQ-25) Questionnaire Total Score at Week 24 - LOCF
Time Frame: Baseline to week 24
The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.
Baseline to week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Collaborators

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

January 26, 2012

First Submitted That Met QC Criteria

January 26, 2012

First Posted (Estimate)

January 30, 2012

Study Record Updates

Last Update Posted (Estimate)

November 13, 2014

Last Update Submitted That Met QC Criteria

November 5, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGFTe-RVO-1027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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