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

Abstract

<p>Introduction: 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 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 42.2 ± 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.

Conclusion: 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. </p>.

Keywords: Antivascular endothelial growth factor; Intravitreal aflibercept; Macular oedema; Observational study; Optical coherence tomography; Real-world evidence; Retinal disease; Retinal vein occlusion.

Fig. 1.

Patient disposition. ^aAll patients who received an IVT-AFL treatment within ±60 days of the 12-/24-month visit window. BRVO, branch retinal vein occlusion; CRVO, central retinal vein occlusion; FAS, full analysis set; IVT-AFL, intravitreal aflibercept; SAS, safety analysis set.

Fig. 2.

Mean change in VA (LOCF) over 24 months in patients with (a) treatment-naïve and (b) pretreated macular oedema secondary to RVO in Italy. Patients were treated for up to 24 months with intravitreal aflibercept in routine clinical practice. The mean VA change data reported here are based on the nearest VA assessments within the +14/−13-day visit windows at 4-week (28-day) intervals. BL, baseline; BRVO, branch retinal vein occlusion; CRVO, central retinal vein occlusion; LOCF, last observation carried forward; RVO, retinal vein occlusion; VA, visual acuity; W, week.

Fig. 3.

Mean change in VA (LOCF) from baseline to months 12 and 24 following IVT-AFL treatment in patients with RVO in Italy stratified by baseline VA. LOCF, last observation carried forward; RVO, retinal vein occlusion; VA, visual acuity.

Fig. 4.

Absolute mean CRT over 24 months in patients with (a) treatment-naïve and (b) pretreated macular oedema secondary to RVO in Italy. The CRT data reported here are based on the nearest OCT assessments within the +14-/−13-day visit windows at 4-week intervals. BL, baseline; BRVO, branch retinal vein occlusion; CRT, central retinal thickness; CRVO, central retinal vein occlusion; OCT, optical coherence tomography; RVO, retinal vein occlusion; W, week.

Fig. 5.

Change in retinal fluid status over 24 months in treatment-naïve patients in Italy. Proportions of patients with IRF and SRF present are calculated based on the number of patients (n) who underwent a fluid assessment at each of the indicated time points. IRF, intraretinal fluid; SRF, subretinal fluid.