Real-world outcomes with ranibizumab 0.5 mg treatment in French patients with visual impairment due to macular edema secondary to central retinal vein occlusion: 6-month results from the 24-month BOREAL-CRVO study

Abstract

Purpose : To assess the effectiveness and safety of ranibizumab 0.5 mg in French patients with visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO) from the 24-month BOREAL-CRVO study. Here, we present 6-month follow-up results from this study.

Methods : This is a mandatory, non-interventional, multicenter, post-authorization, observational cohort study conducted in France. Adult patients (aged ≥18 years) with a confirmed diagnosis of CRVO and for whom ranibizumab therapy was initiated by the treating physician were included in the study. The primary endpoint was the mean change in best-corrected visual acuity (BCVA) at Month 6 compared with baseline. Key secondary endpoints were the proportion of patients with BCVA gain or loss of ≥5, ≥10, and ≥15 letters at Month 3 and Month 6, mean change in central subfield thickness (CSFT) at Month 6, treatment exposure to ranibizumab, and safety up to Month 6.

Results : Of the 196 enrolled patients, 180 patients (91.8%) completed the 6-month follow-up. At baseline, the mean (standard deviation [SD]) age of the patients was 70.5 (14.4) years and 50.6% were male. The mean baseline BCVA and CSFT were 40.5 (25.7) letters and 649.0 (216) μm, respectively. At Month 6, the mean change in BCVA from baseline was 9.5 letters [95%CI: 5.5, 13.5], with 30.6% of patients with BCVA >70 letters vs 8.3% at baseline. The proportion of patients with BCVA gain of ≥5, ≥10, and ≥15 letters and those with BCVA loss of ≥5, ≥10, and ≥15 letters at Month 3 and Month 6 are displayed in Figure 1. The mean (SD) change in CSFT at Month 6 from baseline was −264.0 (270) μm. The mean (SD) number of ranibizumab injections in the study eye was 3.6 (1.2) and the number of visits was 7.3 (2.3). No new safety findings were identified.

Conclusions : Ranibizumab 0.5 mg treatment improves visual acuity in patients with visual impairment due to macular edema secondary to CRVO in routine clinical practice. The safety profile of ranibizumab was consistent with previously reported CRVO studies.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.