Real-world outcomes with ranibizumab 0.5 mg treatment in French patients with visual impairment due to diabetic macular edema: 12-month results from the 36-month BOREAL-DME study

Abstract

Purpose : To assess the effectiveness and safety of ranibizumab 0.5 mg in French patients with visual impairment due to diabetic macular edema (DME) from the 36-month BOREAL-DME study. Here, we present 12-month follow-up results from this study.

Methods : This is a mandatory, noninterventional, multicenter, post-authorization, observational cohort study conducted in France. Patients with Type 1 or 2 diabetes aged ≥18 years who had a reduction in BCVA due to DME 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 12 compared with baseline. Key secondary endpoints were the proportion of patients with BCVA gain or loss of ≥5, ≥10, and ≥15 letters at Month 12, mean change in central subfield thickness (CSFT) at Month 12, treatment exposure to ranibizumab, and safety up to Month 12.

Results : Of the 344 enrolled patients, 242 patients (83.4%) completed the 12-month follow-up. At baseline, the mean (standard deviation [SD]) age of the patients was 66.1 (11.0) years and 56.6% were male. The mean duration of DME was more than 6 months in 43.8% of patients, mean HbA_1c was 7.6% (1.4), and 66.5% of patients presented with bilateral DME. The mean baseline BCVA and CSFT were 59.2 letters [95% confidence interval (CI): 57.0, 61.0] and 457.0 μm [95%CI: 438, 476], respectively. At Month 12, the mean change in BCVA from baseline was 7.4 letters [95%CI: 5.4, 9.4], with 36.8% of patients with BCVA >70 letters vs 13.2% 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 12 are displayed in Figure 1. The mean change in CSFT at Month 12 from baseline was −129.0 μm [95%CI: −146.0, −103.0]. The mean (SD) number of ranibizumab injections in the study eye was 5.1 (2.3). No new safety findings were identified.

Conclusions : Ranibizumab 0.5 mg treatment improves visual acuity in patients with visual impairment due to DMA in routine clinical practice with fewer injections than reported in clinical trials. The safety profile of ranibizumab was consistent with previously reported DME studies.

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