[06/05/2023] 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
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L’aflibercept intravitreen en pratique clinique courante en France: resultats AURIGA a 24 mois chez des patients naifs de
traitement presentant un d'œdeme maculaire diabetique
Laurent Vélasque (Centre Rétine Gallien Bordeaux), Laurent Kodjikian (Lyon, France), Helmut Allmeier (Basel, Switzerland), Tobias Machewitz (Berlin, Germany), Audrey Giocanti
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-nai?ve patients with DME in France.
Mate?riels et Me?thode
AURIGA was a 24-month, prospective, multicenter observational study. Eligible patients (aged ?18 years) with treatment-nai?ve 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
Mode?rateur : C. Creuzot-Garcher (Dijon), N. Leveziel (Poitiers) was monitored throughout the study.
Improvements in VA (+5.5 letters) and CRT (?126 ?m) at Month 24 were consistent with previous real-world evidence; <50% of patients received ?7 injections by Month 12, reflecting
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.
L. Velasque (Bordeaux), L. KodjikiCan (Lyon), H. Allmeier (Basel, Suisse), T. Machewitz (Berlin, Allemagne), A. Giocanti (Bobigny)