Intravitreal aflibercept in routine clinical practice: 24-month results from the global cohort of pretreated patients with diabetic macular edema in the AURIGA study

Abstract

Purpose : AURIGA evaluated intravitreal aflibercept (IVT-AFL) in patients with diabetic macular edema (DME) or macular edema secondary to retinal vein occlusion (RVO) treated in routine clinical practice. Patients were enrolled from 11 countries, making AURIGA the largest real-world study to date in these patients. Here, we report the 24-month outcomes in the cohort of pretreated patients with DME from China, Italy, and Russia.

Methods : AURIGA (NCT03161912) enrolled patients aged ≥18 years who had previously received therapy (intravitreal anti-VEGF injections or intravitreal steroids) for DME. Patients received IVT-AFL for up to 24 months at physician discretion according to local practice and regulations. The primary endpoint was mean change in visual acuity (VA; Early Treatment Diabetic Retinopathy Study [ETDRS] letters) from baseline to Month (M)12. Statistics were descriptive and no formal hypothesis testing was planned. Safety was monitored throughout the study.

Results : Of 386 patients enrolled with pretreated DME (mean age: 62.9 years; female: 57.8%), the median duration from diagnosis to IVT-AFL treatment was 15.7 months (range: 0.0–285.8). From baseline (mean±SD: 50.8±19.5 letters), mean (95% CI) change in VA was +7.4 (5.5, 9.4) letters by M12 and +8.1 (6.1, 10.1) letters by M24. By M12 and M24, 32% and 33% of patients gained ≥15 letters. From baseline (465±148 µm), mean change in CRT was −162±170 µm by M12 and −169±173 µm by M24. The mean number of IVT-AFL injections was 4.9±2.4 by M12 and 6.2±3.6 by M24; 26.8% of patients received ≥7 injections by M12 and 4.9% received ≥13 injections by M24. The last completed treatment interval was ≥16 weeks for 99/355 (27.9%) patients by M24. There were no cases of retinal vasculitis, and one case of endophthalmitis.

Conclusions : In AURIGA, up to 24 months of IVT-AFL treatment resulted in clinically meaningful functional and anatomic improvements in patients with DME who had received prior treatment. The improvements observed after the initial monthly injections administered through 6 months remained stable over the course of the study, demonstrating relative durability of treatment benefit despite decreased injection frequencies and increased inter-injection intervals over time. The safety profile of IVT-AFL was consistent with previous studies.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.