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
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
1 other identifier
interventional
183
3 countries
56
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2012
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2012
CompletedFirst Posted
Study publicly available on registry
January 30, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedResults Posted
Study results publicly available
November 13, 2014
CompletedNovember 13, 2014
November 1, 2014
1.3 years
January 26, 2012
November 5, 2014
November 5, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF
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 Outcomes (3)
Change From Baseline to Week 24 in BCVA Score - LOCF
Baseline to Week 24
Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF
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
Baseline to week 24
Study Arms (2)
Macular Laser Photocoagulation Treatment (Control)
SHAM COMPARATORParticipants 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.
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- Adults ≥ 18 years of age with foveal center-involved macular edema (ME) secondary to BRVO diagnosed within 12 months before the screening visit
- ETDRS BCVA: letter score of 73 to 24 (20/40 to 20/320) in the study eye at screening and at day 1
- Provide signed informed consent
You may not qualify if:
- Current bilateral manifestation of BRVO
- Uncontrolled glaucoma defined as ≥ 25 mmHg on optimal medical regimen, or previous filtration surgery in either the study eye or the fellow eye
- 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)
- Uncontrolled diabetes mellitus (DM)
- Previous use of intraocular corticosteroids or anti-angiogenic drugs in the study eye
- Use of periocular corticosteroids in the study eye within 3 months before day 1
- Use of intraocular or periocular corticosteroids or anti-angiogenic drugs in the fellow eye within 3 months before day 1
- Previous administration of systemic anti-angiogenic medications
- Panretinal scatter photocoagulation, sector laser photocoagulation, or macular grid photocoagulation in the study eye
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Regeneron Pharmaceuticalslead
- Bayercollaborator
Study Sites (56)
Unknown Facility
Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Beverly Hills, California, United States
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La Jolla, California, United States
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Mountain View, California, United States
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Palm Desert, California, United States
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Sacramento, California, United States
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Colorado Springs, Colorado, United States
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Fort Myers, Florida, United States
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Miami, Florida, United States
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Plantation, Florida, United States
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Stuart, Florida, United States
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Tampa, Florida, United States
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Winter Haven, Florida, United States
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Augusta, Georgia, United States
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Chicago, Illinois, United States
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Baltimore (2 Locations), Maryland, United States
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Hagerstown, Maryland, United States
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Boston (2 Locations), Massachusetts, United States
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Grand Rapids, Michigan, United States
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Jackson, Michigan, United States
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Southfield, Michigan, United States
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Florissant, Missouri, United States
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Lincoln, Nebraska, United States
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Las Vegas, Nevada, United States
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Teaneck, New Jersey, United States
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Orchard Park, New York, United States
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Syracuse, New York, United States
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Charlotte, North Carolina, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Kingston, Pennsylvania, United States
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West Mifflin, Pennsylvania, United States
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Florence, South Carolina, United States
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Ladson, South Carolina, United States
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West Columbia, South Carolina, United States
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Rapid City, South Dakota, United States
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Nashville, Tennessee, United States
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Abilene, Texas, United States
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Fort Worth, Texas, United States
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Harlingen, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Mississauga, Ontario, Canada
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Toronto, Ontario, Canada
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Urayasu-shi, Chiba, Japan
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Fukushima, Fukushima, Japan
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Amagasaki, Hyōgo, Japan
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Kagoshima, Kagoshima-ken, Japan
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Kyoto, Kyoto, Japan
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Osaka, Osaka, Japan
Unknown Facility
Hamamatsu, Shizuoka, Japan
Related Publications (1)
Shalchi Z, Mahroo O, Bunce C, Mitry D. Anti-vascular endothelial growth factor for macular oedema secondary to branch retinal vein occlusion. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD009510. doi: 10.1002/14651858.CD009510.pub3.
PMID: 32633861DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trials Administrator
- Organization
- Regeneron
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2012
First Posted
January 30, 2012
Study Start
April 1, 2012
Primary Completion
August 1, 2013
Study Completion
March 1, 2014
Last Updated
November 13, 2014
Results First Posted
November 13, 2014
Record last verified: 2014-11