Aflibercept in a real-world setting: the AURIGA study : 24-month results of the German cohort of treatment-naïve patients with macular edema following retinal vein occlusion receiving intravitreal aflibercept

Abstract

AURIGA is the largest prospective real-world study to evaluate intravitreal aflibercept 2 mg (IVT-AFL) treatment of macular edema (ME) secondary to retinal vein occlusion (RVO) and diabetic macular edema. Here we present the 24-month data from the German cohort of treatment-naïve patients with ME due to RVO. Treatment-naïve patients with ME secondary to RVO were treated with IVT-AFL 2 mg in the routine clinical practice. The primary endpoint was mean change in visual acuity (VA, early treatment diabetic retinopathy, ETDRS, letters) at month12 compared to baseline. Analyses were descriptive. Analysis included 130 patients with RVO (n = 61, 46.9% with central RVO, n = 69, 53.1% with branch RVO). The mean (±SD) time the RVO patients remained in the study was 18.4 ± 7.4months. The mean VA gain (95% confidence interval) in the overall cohort was +10.9 (7.5-14.2) letters at month12 and +9.7 (6.1-13.3) at month24 (baseline VA 56.5 ± 18.9 letters). At 24months, 67% of RVO patients gained ≥5letters and 40% gained ≥15letters. The mean number of injections was 4.4 ± 1.3 up to month6, 6.2 ± 2.7 up to month12 and8.2 ± 4.5 up to month24. The mean central retinal thickness (CRT) reduction was -206µm (-252 to -160µm) at 12months and -219µm (-263 to -175µm) at 24months (baseline CRT 507 ± 177 µm). The safety profile was consistent with that of previous studies. In the German AURIGA cohort of treatment-naïve patients with ME secondary to RVO, IVT-AFL 2 mg treatment in clinical practice resulted in rapid and clinically relevant VA gains and areduction in CRT. These results were largely maintained over 24months despite the low injection frequency from month6.