Study to Assess the Clinical Efficacy and Safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in Patients With Branch Retinal Vein Occlusion (BRVO)
NCT ID: NCT01521559
Last Updated: 2014-11-13
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
183 participants
INTERVENTIONAL
2012-04-30
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Macular Laser Photocoagulation
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.
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)
Interventions
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Macular Laser Photocoagulation
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Phoenix, Arizona, United States
Tucson, Arizona, United States
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 Springs, Colorado, United States
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
Augusta, Georgia, United States
Chicago, Illinois, United States
Baltimore (2 Locations), Maryland, United States
Hagerstown, Maryland, United States
Boston (2 Locations), Massachusetts, United States
Grand Rapids, Michigan, United States
Jackson, Michigan, United States
Southfield, Michigan, United States
Florissant, Missouri, United States
Lincoln, Nebraska, United States
Las Vegas, Nevada, United States
Teaneck, New Jersey, United States
Orchard Park, New York, United States
Syracuse, New York, United States
Charlotte, North Carolina, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Kingston, Pennsylvania, United States
West Mifflin, Pennsylvania, United States
Florence, South Carolina, United States
Ladson, South Carolina, United States
West Columbia, South Carolina, United States
Rapid City, South Dakota, United States
Nashville, Tennessee, United States
Abilene, Texas, United States
Fort Worth, Texas, United States
Harlingen, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Seattle, Washington, United States
Milwaukee, Wisconsin, United States
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Mississauga, Ontario, Canada
Toronto, Ontario, Canada
Urayasu-shi, Chiba, Japan
Fukushima, Fukushima, Japan
Amagasaki, Hyōgo, Japan
Kagoshima, Kagoshima-ken, Japan
Kyoto, Kyoto, Japan
Osaka, Osaka, Japan
Hamamatsu, Shizuoka, Japan
Countries
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References
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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.
Other Identifiers
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VGFTe-RVO-1027
Identifier Type: -
Identifier Source: org_study_id