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)
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|ClinicalTrials.gov Identifier: NCT01521559|
Recruitment Status : Completed
First Posted : January 30, 2012
Results First Posted : November 13, 2014
Last Update Posted : November 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Branch Retinal Vein Occlusion||Procedure: Macular Laser Photocoagulation Drug: Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||183 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||March 2014|
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)
- 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.
- 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.
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521559
|Study Director:||Clinical Trial Management||Regeneron Pharmaceuticals|