Visual Acuity (VA) Outcomes and Impact of Baseline (BL) Perfusion Status in VIBRANT
Abstract
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.
