Name

L’aflibercept intravitréen en pratique clinique courante en France: résultats AURIGA à 24 mois chez des patients naïfs de traitement présentant un d'œdème maculaire diabétique

The 24-month AURIGA (NCT03161912) study evaluated intravitreal aflibercept 2mg (IVT-AFL) treatment of diabetic macular edema (DME) or macular edema secondary to retinal vein occlusion (RVO) in routine clinical practice. The study provided important insights into IVT-AFL effectiveness and treatment patterns across 11 countries. Here, we report real-world, 24-month outcomes for treatment-naïve patients with DME in France.

AURIGA was a 24-month, prospective, multicenter observational study. Eligible patients (aged ≥18 years) with treatment-naïve DME were treated with IVT-AFL for up to 24 months by physician discretion, and according to local regulations. The primary endpoint was change in visual acuity (VA) from baseline to Month (M) 12. Secondary endpoints included change in VA, change in central retinal thickness (CRT), and number of IVT-AFL injections by M6, M12, and M24. Statistics were descriptive, and no formal hypothesis testing was planned. Safety was monitored throughout the study.

There were 164 patients (mean age: 62.5 years; female: 37.8%) in the study, with a median of 0.7 months from diagnosis to first injection. From a baseline mean±SD VA of 67.1±10.6 letters, mean (95% CI) VA improved by +6.1 (4.1, 8.1) letters at M6, +5.9 (4.1, 7.8) letters at M12, and +5.5 (3.7, 7.3) letters at M24; 62% and 17% of patients gained ≥5 and ≥15 letters by M24, respectively. Baseline mean CRT was 453±128 µm; mean CRT change from baseline was −129 (−148, −110) µm at M6, −128 (−147, −109) µm at M12, and −126 (−145, −107) µm at M24. Mean number of IVT-AFL injections was 5.0±1.4 by M6, 6.6±2.6 by M12, and 7.8±4.0 by M24, with 48.8% of patients receiving ≥7 injections by M12 and 53.7% receiving ≥7 injections by M24. No new safety concerns were identified, and no cases of endophthalmitis or retinal vasculitis were reported.

Improvements in VA (+5.5 letters) and CRT (&minus;126 &micro;m) at Month 24 were consistent with previous real-world evidence; <50% of patients received &ge;7 injections by Month 12, reflecting relative undertreatment compared with randomized control trials, suggesting greater VA gains may have been achieved with more frequent treatment in the first year. Following a mean of 5.0 injections in the first 6 months, rapid improvements in VA and CRT were reported; despite the subsequent decrease in injection frequency, the improvements were maintained, indicating long-term durability of IVT-AFL treatment.

Clinically meaningful functional and anatomic improvements were achieved in the DME treatment-na&iuml;ve cohort in France following up to 24 months of IVT-AFL treatment.

This abstract is presented on behalf of the AURIGA study investigators.