Intravitreal Aflibercept for Macular Edema Following Branch XXXX : 52-Week Results of the VIBRANT Study.

@entity1 @entity227 @entity231 @entity2994 @entity1103
PURPOSE: To determine week 52 efficacy and safety outcomes in eyes with @entity1103 after @entity2994 ( @entity2994 ) treated with 2 mg intravitreal aflibercept injection (IAI) compared with grid laser. DESIGN: VIBRANT was a double-masked, randomized, phase 3 trial. @entity1 : Eyes randomized and treated in VIBRANT were followed to week  52. METHODS: In the IAI group, eyes received IAI every 4 weeks through week 24 and IAI every 8 weeks through week 48 with rescue grid laser if needed at week 36. In the grid laser group, all eyes received grid laser at baseline and, if prespecified rescue criteria were met, 1 additional laser from week 12 to 20 and IAI every 8 weeks after 3 monthly doses from week 24 onward (the laser/IAI group). MAIN OUTCOME MEASURES: The primary outcome measure was percentage of eyes with improvement from baseline best-corrected visual acuity (BCVA) letter score >= 15 at week 24. All outcome measures at week 52 were exploratory, and P values are considered nominal. RESULTS: The percentage of eyes with improvement from baseline letter score >= 15 in the IAI and laser/IAI groups was 52.7% versus 26.7% (P  = 0.0003) at week 24 and 57.1% versus 41.1% (P  = 0.0296) at week 52. The corresponding mean change from baseline BCVA letter score was 17.0 versus 6.9 (P < 0.0001) at week 24 and 17.1 versus 12.2 (P  = 0.0035) at week 52. The mean reduction from baseline central retinal thickness was 280.5  m versus 128.0  m (P < 0.0001) at week 24 and 283.9  m versus 249.3  m (P  = 0.0218) at week 52. In the IAI group, 10.6% of eyes received rescue laser at week 36, and in the laser/IAI group, 80.7% received rescue IAI from week 24 to week 48. Traumatic @entity231 in 1 eye (1.1%) in the IAI group was the only ocular serious adverse event. CONCLUSIONS: After 6 monthly IAI, injections every 8 weeks maintained control of @entity1103 and @entity227 through week 52. In the laser group, rescue IAI given from week 24 onward resulted in substantial visual improvements at week  52.
