Name

169 - Evaluation en pratique courante de l’évolution de l'acuité visuelle des patients initiant un traitement par ranibizumab pour une baisse de l’acuité visuelle due à un œdème maculaire diabétique : Résultats à 24 mois de l’étude de 36 mois BOREAL OMD

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 24-month follow-up results from this study.

This is a mandatory, non-interventional, 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. Primary endpoint was the mean change in best- corrected visual acuity (BCVA) at Month 12 compared with baseline. Key secondary endpoints at the end of follow-up were the mean change in best-corrected visual acuity (BCVA) compared with baseline and proportion of patients with BCVA gain or loss of≥10, and ≥15 letters, mean change in central subfield thickness (CSFT), treatment exposure to ranibizumab, and safety, respectively.

Of the 290 enrolled patients, 224 patients (77.2%) completed the 24-month follow-up. At baseline, the mean (standard deviation [SD]) age of the patients was 66.2 (10.8) years and 55.9% were male. The mean duration of DME was more than 6 months in 43.1% patients, mean HbA1c was 7.5% (1.4), and 64.1% patients presented with bilateral DME. The mean baseline BCVA and CSFT were 59.2 letters [95% confidence interval (CI): 57.4, 61.0] and 452 μm [95%CI: 435, 469], respectively.

At Month 24, the mean change in BCVA from baseline was + 6.4 letters [95%CI: 4.2, 8.7], with 46.2% of patients with BCVA >70 letters vs 14.1% at baseline. At Month 24, the proportion of patients with BCVA gain of ≥10, and ≥15 letters were 39.1% and 27.4%, respectively and those with BCVA loss ≥10, and ≥15 letters were 11.2% and 8.1%, respectively. The mean change in CSFT at Month 24 from baseline was −118 μm [95%CI: -143;-94]. The mean (SD) number of ranibizumab injections in the study eye was 6.5 (3.7). No new safety findings were identified.

This 24-month analysis of the effectiveness of ranibizumab 0.5 mg in patients with DME showsthe functional and anatomic effects of ranibizumab treatment at 24 months in routine clinicalpractice, with a lower number of injections than reported in clinical trials.

The safety profile of ranibizumab was consistent with previously reported DME studies.

The BOREAL-DME study confirms the effectiveness in real life of ranibizumab for the treatment of visual impairment due to DME. Ranibizumab was generally well tolerated with no new safety concerns.