Aflibercept in the clinical routine: the AURIGA study : The 24-month results of the German cohort of treatment-naïve patients with diabetic macular edema receiving intravitreal aflibercept

Abstract

AURIGA is the largest prospective real-world study to evaluate intravitreal aflibercept (IVT-AFL) treatment of diabetic macular edema (DME) and macular edema secondary to retinal vein occlusion. This article presents 24-month data from the German cohort of treatment-naïve patients with DME. Treatment-naïve patients (≥ 18years) with DME were treated with IVT-AFL at the discretion of the physician in clinical practice. The primary endpoint was mean change in visual acuity (early treatment diabetic retinopathy, ETDRS, letters) at month12 compared to baseline. Statistical analyses were descriptive. The analysis included data from 150 DME patients (54.7% male). At months6, 12 and24, mean (95% confidence interval) visual acuity gains of4.6 (2.6; 6.5), 4.0 (2.1; 6.5) and 5.0 (3.0; 6.9) letters from baseline (mean ±SD: 65.0 ± 15.3 letters) and reductions in retinal thickness of 86µm (109; 64µm), 70µm (94; 43µm) and 75µm (103; 47µm) from baseline (mean ±SD: 391 ± 132 µm), respectively, were achieved. At month24, 54% of patients gained ≥ 5 letters and 22% ≥ 15 letters. Patients received amean number of 5.0 ± 1.6injections until month6, 7.1 ± 3.2 until month12 and9.0 ± 5.3 until month24, 68% of patients received ≥ 5injections until month6 and 56% ≥ 7injections within the first year. The safety profile was consistent with previous studies. In the German AURIGA cohort, treatment-naïve DME patients achieved aclinically relevant gain in visual acuity as well as reduction in central retinal thickness following IVT-AFL treatment in clinical practice. From month6 onwards, improvements were maintained despite alow injection frequency over 24months. In comparison with previous real-world studies, care of DME patients in clinical practice seems to have improved; however, there is still room for further improvement.