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L'aflibercept en pratique clinique courante en France : Résultats à 24 mois de l'étude AURIGA chez des patients naïfs de traitement atteints d’œdème secondaire à une occlusion veineuse rétinienne

AURIGA (NCT03161912) evaluated intravitreal aflibercept (IVT-AFL) treatment of diabetic macular edema or macular edema secondary to retinal vein occlusion (RVO) in routine clinical practice in 2481 patients. This study provides important insights into IVT-AFL effectiveness and treatment patterns across 11 countries. Here, we report 24-month outcomes for treatment-naïve patients with RVO in France.

AURIGA was a 24-month, prospective, multicenter, observational study. Eligible patients (aged ≥18 years) with treatment-naïve central RVO (CRVO) or branch RVO (BRVO) were treated with IVT-AFL between 2017 and 2021 for up to 24 months by physician discretion and according to local regulations. The primary endpoint was change in visual acuity (VA) from baseline (BL) to Month (M)12. Secondary endpoints included VA change by M24, central retinal thickness (CRT) change by M12 and M24, 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.

In 138 patients (mean age: 67.7 years; female: 50.0%), mean VA at BL was 41.1±24.1 (CRVO) and 59.0±17.4 (BRVO) letters. From BL, mean (95% CI) VA increased by +12.1 (5.8, 18.4) letters (CRVO) and +16.1 (12.4, 19.8) letters (BRVO) at M12, and +9.7 (3.1, 16.3) letters (CRVO) and +13.1 (8.3, 18.0) letters (BRVO) at M24. At BL, CRT was 673±200 µm (CRVO) and 523±158 µm (BRVO). From BL, mean±SD CRT decreased by 325±245 µm (CRVO) and 233±164 µm (BRVO) at M12, and 318±264 µm (CRVO) and 219±169 µm (BRVO) at M24. Overall, the mean number of IVT-AFL injections was 4.4±1.2 by M6, 6.5±2.6 by M12, and 8.8±4.7 by M24. By M6, 51.4% of patients received ≥5 injections; 52.2% of patients received ≥7 injections by M12 and 42.8% received ≥10 injections by M24. No cases of retinal vasculitis or intraocular inflammation, including endophthalmitis, were reported.

Clinically meaningful functional and anatomic improvements were achieved with up to 24 months of IVT-AFL treatment in patients with treatment-naïve CRVO and BRVO in France. These results were comparable to those observed in the AURIGA Global treatment-naïve RVO cohort, as well as with those published in other interventional studies, despite differences in VA and CRT at BL. The safety profile of IVT-AFL was consistent with that observed in previous studies.

IVT-AFL provided clinically meaningful improvements in VA, which were largely maintained over a period of 24 months, suggesting long-term durability of IVT-AFL treatment can be achieved in routine clinical practice.