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David S Boyer; Efficacy and Safety of Intravitreal Aflibercept Injection (IAI) for Treatment of Macular Edema Following Branch Retinal Vein Occlusion (BRVO): 52-Week Results of the VIBRANT Study. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):3749.
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© ARVO (1962-2015); The Authors (2016-present)
To evaluate the efficacy and safety of IAI compared with laser grid photocoagulation in macular edema following BRVO.
VIBRANT was a double-masked, 52-week, phase 3 trial that randomized 183 BRVO eyes with macular edema to treatment with either IAI 2 mg every 4 weeks from baseline through week 24 or grid laser at baseline. From week 24, IAI eyes received IAI 2 mg every 8 weeks and, if needed, laser rescue at week 36; eyes in the laser group that required rescue received IAI 2 mg every 8 weeks after 3 monthly doses. The primary endpoint was the proportion of eyes that gained ≥15 letters in best-corrected visual acuity (BCVA) from baseline at week 24.
The proportions of eyes that gained ≥15 letters from baseline were 52.7% for the IAI group vs 26.7% for the laser group (P=0.0003) at week 24, and 57.1% for the IAI group vs 41.1% for the laser/IAI group (P=0.0296) at week 52. The corresponding mean change from baseline BCVA was 17.0 vs 6.9 letters (P<0.0001) at week 24, and 17.1 vs 12.2 letters (P=0.0035) at week 52 for the IAI and laser/IAI groups, respectively. The corresponding mean CRT reduction from baseline was 280.5 vs 128.0 µm (P<0.0001) at week 24, and 283.9 vs 249.3 µm (P=0.0218) at week 52, respectively. During weeks 24-48, 67 laser eyes (67/83 eyes completing week 24 [80.7%]) received a mean of 4.4 IAI; the median time (range) to the first rescue IAI was 24.9 weeks (23.1-48.4 weeks). Overall, 9 IAI eyes (9/85 eyes completing week 24 [10.6%]) received rescue laser at week 36. Traumatic cataract in an IAI patient (1.1%) was the only ocular serious adverse event that occurred in 52 weeks. One non-fatal stroke (1.1%) occurred before week 24 in a laser patient, and one non-fatal myocardial infarction (1.1%) occurred after week 24 in a laser/IAI patient who had received IAI.
IAI 2q4 provided statistically significant and clinically relevant visual benefits over laser at week 24. IAI given every 8 weeks maintained these improvements through week 52.
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