Real-world Intravitreal Aflibercept 2 mg Treatment of Macular Oedema Secondary to Retinal Vein Occlusion in Italy: 24-month Results from the AURIGA Observational Study.

Background: This subgroup analysis of the global AURIGA study evaluated intravitreal aflibercept 2 mg (IVT-AFL) effectiveness and treatment patterns in routine practice in Italy in patients with macular oedema secondary to branch or central retinal vein occlusion (BRVO/CRVO).

Methods: AURIGA (NCT03161912) was a 24-month, prospective observational study in patients for whom IVT-AFL treatment had already been prescribed by their physician. All clinical decisions were according to physician discretion and local practice. Statistical analyses were descriptive only.

Results: In Italy, 152 treatment-naïve and 50 pretreated patients participated across 27 centres. Mean (95% confidence interval) change in visual acuity (VA) from baseline to Month (M)12 in treatment-naïve patients was +10.3 (7.0, 13.6) and +12.2 (5.6, 18.8) letters for BRVO and CRVO (baseline: 55.3±20.3 and 44.5±25.5 letters), and pretreated patients gained +6.6 (0.3, 13.0) and +14.6 (5.5, 23.8) letters for BRVO and CRVO (baseline: 56.0±15.9 and 42.4±23.5 letters). In treatment-naïve patients, VA gains by M12 after a mean of 4.8 injections were maintained through M24 after a mean of 5.7 injections from baseline; in pretreated patients, M12 gains were not maintained, despite a similar mean of 5.8 injections by M24. Most injections were received within the first 6 months, with a marked reduction in injection frequency thereafter.

Conclusions: Robust VA improvements were observed in treatment-naïve patients with RVO in Italy following IVT-AFL treatment for up to 24 months in routine practice, despite a low injection frequency. However, guidelines indicate that regular, proactive treatment beyond the acute stage is required to improve long-term outcomes.