Abstract
Purpose :
AURIGA evaluated intravitreal aflibercept (IVT-AFL) in patients with macular edema secondary to retinal vein occlusion (RVO) or diabetic macular edema (DME) treated in routine clinical practice. Patients were enrolled from 11 countries, making AURIGA the largest real-world study to date in IVT-AFL-treated patients with RVO or DME. Here, we report the 24-month outcomes in the treatment-naïve central RVO (CRVO) cohort from France, Germany, Italy, and Taiwan.
Methods :
AURIGA (NCT03161912) was a prospective observational study. Eligible patients (aged ≥18 years) with treatment-naïve CRVO were treated with 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. Safety was monitored throughout the study.
Results :
In 228 treatment-naïve patients with CRVO (mean age: 68.7 years; male: 54.8%), median duration from diagnosis to IVT-AFL treatment was 0.3 months (range: 0.0–53.5). From baseline (mean±SD: 45.5±23.8 letters), mean (95% CI) change in VA was +10.5 (7.3, 13.8) letters by M12 and +8.8 (5.3, 12.2) letters by M24; 60.7% and 45.5% of patients gained ≥5 and ≥15 letters by M24. From baseline (626±209 μm), mean CRT improved by −303±239 μm by M24. Mean number of IVT-AFL injections was 4.1±1.3 by M6, 5.8±2.6 by M12, and 7.4±4.3 by M24; 40.4% of patients received ≥7 injections by M12 and 16.2% received ≥13 injections by M24. At M24, the last completed treatment interval was ≥10 and ≥12 weeks in 47.8% and 33.9% of patients. No cases of endophthalmitis or retinal vasculitis were reported.
Conclusions :
Clinically relevant improvements in functional and anatomic outcomes were achieved in the AURIGA CRVO naïve cohort following IVT-AFL treatment of up to 24 months. Improvements were maintained over the study period despite decreased injection frequency after the first 6 months, indicating long-term durability of outcomes with IVT-AFL treatment. Even with observed differences in treatment patterns, mean age, and baseline VA, considerable gains were reported in all countries involved. 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.