This paper is a sub-group analysis of the real-world effectiveness, treatment patterns, and safety of IVT-AFL in patients with macular oedema secondary to retinal vein occlusion (RVO) in Italy. One hundred and fifity-two treatment-naïve and 50 pretreated patients were enrolled across 27 centres. The baseline demographics and disease characteristics of patients were as follows. In the treatment-naïve cohort, the mean age was 66.8 years (range 34–92 years), 54.6% were male, the mean baseline visual acuity (VA) was 50.8 ±23.1 letters, and the mean baseline central retinal thickness (CRT) was 549 ±196µm. These baseline characteristics were similar in the pretreated cohort: mean age of 71.3 years (range 38–86 years), 50% male, mean baseline VA of 50.6 ±20.2 letters, and mean baseline CRT of 466 ±161µm. The mean duration between RVO diagnosis and the first IVT AFL treatment was 1.0 month in the treatment naïve cohort and 23.8 months in the pretreated cohort. Mean (95% confidence interval) change in 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 branch (BRVO) and central (CRVO) (baseline: 55.3 ±20.3 and 44.5 ±25.5 letters.) The 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). A rapid decrease in mean CRT was observed in all treatment cohorts from a mean baseline of 483 ±148 and 637 ±217µm for the BRVO and CRVO treatment-naïve cohorts and 427 ±119 and 533 ±204µm for the BRVO- and CRVO-pretreated cohorts. In the overall RVO cohorts, the mean (95% CI) changes in CRT from baseline to month 24 was −219 (−257, −180)µm for the treatment-naïve patients (baseline: 549 ±196µm) and −150 (−200, −100)µm for the pretreated patients (baseline: 466 ±161µm). In the Italian cohort, the mean change in VA from baseline to month 12 in the AURIGA study was +11.1 letters for the overall treatment-naïve cohort (+10.3 letters for BRVO and +12.2 letters for CRVO) and +9.7 letters for the overall pretreated cohort (+6.6 VA gains at month 12 in treatment-naïve patients were maintained throughout the study, with a slight further increase observed by month 24 after a mean total of 5.7 injections from baseline). In contrast, in the pretreated cohort, mean VA gains at month 12 were not maintained through month 24, despite a similar mean total of 5.8 injections from base line. The study concluded that robust VA improvements were observed in treatment-naïve patients with RVO following IVT-AFL treatment for up to 24 months, despite a low injection frequency. Strengths: Prospective design, long-term study duration, and recruitment of large number of centres that facilitated robust data collection. Another notable strength of this study is the large cohort of treatment-naïve patients. Limitations: Assessments were not uniform at each visit. Visual acuity measurements, anatomical assessments and treatments were performed by the attending physician using charts and OCT and armamentarium according to the practice at each centre and not all patients attended visits at key study time points. In addition, the pre- treated cohort was small.
Intravitreal Aflibercept (IVT-AFL): treatment of macular oedema secondary to RVO
Reviewed by Sofia Rokerya
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.
CONTRIBUTOR
Sofia Rokerya
MBBS MRCOphth FRCSI, King's College University Hospital, UK.
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