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Visual Acuity (VA) Outcomes and Impact of Baseline (BL) Perfusion Status in VIBRANT
Author(s) -
Feltgen N.,
Asmus F.
Publication year - 2015
Publication title -
acta ophthalmologica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.534
H-Index - 87
eISSN - 1755-3768
pISSN - 1755-375X
DOI - 10.1111/j.1755-3768.2015.0569
Subject(s) - medicine , ophthalmology , macular edema , visual acuity
Purpose Report additional VA outcomes from VIBRANT. Methods VIBRANT was a phase 3 study of intravitreal aflibercept (IVT‐AFL) vs laser for macular edema (ME) due to branch retinal vein occlusion (BRVO). Patients received IVT‐AFL 2 mg every 4 weeks to week 24 (W24) and every 8 weeks thereafter or macular grid laser at BL. Eligible laser patients received IVT‐AFL rescue beginning at W24. Primary endpoint was the proportion of eyes gaining ≥15 letters in best corrected VA (BCVA) at W24. Retina was considered perfused for patients with ≤10 disc areas of capillary nonperfusion at baseline. Results The proportion of eyes gaining ≥15 letters from BL to W24 and W52 was 52.7% vs 26.7% ( P < 0.001) and 57.1% vs 41.1% ( P < 0.03), for IVT‐AFL vs laser; 36.3% and 49.5% of eyes receiving IVT‐AFL gained ≥15 letters by W4 and W12. Overall mean BCVA gain from BL to W24 and W52 was 17.0 vs 6.9 letters ( P < 0.0001) and 17.1 vs 12.2 letters ( P < 0.004), for IVT‐AFL vs laser. W52 results for laser group include patients who received IVT‐AFL rescue. In the laser group, 80.7% received rescue IVT‐AFL between W24 and W48. In perfused patients, mean BCVA gain from BL to W24 and W52 was 14.3 vs 5.7 and 13.7 vs 11.9 letters; in nonperfused patients, it was 19.1 vs 11.3 and 20.0 vs 15.6 letters. The most common ocular AE, conjunctival hemorrhage, occurred in 24.2% (IVT‐AFL) and 15.2% (laser) of patients. Two APTC‐ATEs occurred, both in the laser group. Conclusions Here, IVT‐AFL provided statistically and clinically significant VA benefits over laser at W24 that were maintained at W52. Benefits with AFL treatment were not dependent on baseline perfusion status.