Session Title: Vascular Diseases and Diabetic Retinopathy
Session Date/Time: Friday 18/09/2015 | 11:00-12:30
Paper Time: 11:40
First Author: : N.Feltgen GERMANY
Co Author(s): : J. Heier F. Asmus B. Stemper
PURPOSE:The purpose of the VIBRANT study was to evaluate the efficacy and safety of intravitreal aflibercept (IVT-AFL) compared with macular grid laser photocoagulation for the treatment of macular edema secondary to branch retinal vein occlusion (BRVO). The current analysis examines the impact of baseline retinal perfusion status on best corrected visual acuity (BCVA) and central retinal thickness (CRT) in the VIBRANT study.
VIBRANT was a phase 3, multicenter, randomized, double-masked, active-controlled 52-week trial conducted at 58 sites in North America and Japan.
Patients with macular edema secondary to BRVO were randomized 1:1 to receive IVT-AFL 2 mg every 4 weeks through week 24 (W24) and every 8 weeks thereafter (IVT-AFL group) or macular grid laser at baseline (laser group). In the laser group, eligible patients received IVT-AFL rescue beginning at W24. The primary efficacy endpoint was the proportion of eyes that gained ≥15 letters in BCVA from baseline at W24. Perfused retina was defined as ≤10 disc areas of retinal capillary non-perfusion. Data are described at W24 and W52 for the full analysis set and using the last observation carried forward method to impute for missing values. At W52, the laser group includes those patients who received IVT-AFL rescue treatment.
Proportions of perfused patients in the IVT-AFL vs laser group were 60.4% vs 68.9%, 80.2% vs 67.1%, and 77.9% vs 78.0% at baseline, W24, and W52, respectively. Among perfused patients, mean changes in BCVA from baseline at W24 and W52 were 14.3 and 13.7 (IVT-AFL) and 5.7 and 11.9 (laser) letters. Proportions gaining ≥15 letters (IVT-AFL vs laser) were 43.6% vs 24.2% and 47.3% vs 41.9% at W24 and W52, respectively. Mean changes in CRT from baseline at W24 and W52 were -230.7 and -237.6 (IVT-AFL) and -103.9 and -236.3 (laser) µm. Among nonperfused patients, mean changes in BCVA from baseline at W24 and W52 were 19.1 and 20.0 (IVT-AFL) and 11.3 and 15.6 (laser) letters. Proportions gaining ≥15 letters (IVT-AFL vs laser) were 60.0% vs 37.5% and 65.0% vs 43.8% at W24 and W52, respectively. Mean changes in CRT from baseline at W24 and W52 were -353.7 and -355.3 (IVT-AFL) and -177.4 and -276.5 (laser) µm. In the laser group, 80.7% received rescue IVT-AFL between W24 and W48. The most common ocular AE, conjunctival hemorrhage, occurred in 24.2% (IVT-AFL) and 15.2% (laser) of patients. Two Anti-Platelet Trialists' Collaboration-defined arterial thromboembolic events occurred, both in the laser group.
In the VIBRANT study, monthly IVT-AFL provided statistically significant and clinically important visual benefits that were superior to macular grid laser in macular edema due to BRVO. Benefits in the IVT-AFL group were maintained when the dosing interval was increased to every 8 weeks after W24. Patients in the laser group benefitted from the option of IVT-AFL rescue treatment. The benefits of IVT-AFL over laser were consistent throughout the study, regardless of baseline perfusion status.