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

Abstract

Purpose : To assess the effectiveness and safety of ranibizumab 0.5 mg (RBZ) in treatment-naïve French patients with visual impairment (VI) due to diabetic macular edema (DME) over 24 months (M).

Methods : ETOILE is an ongoing, phase IV, non-interventional, multicenter (n=20), prospective, observational study. Treatment-naïve patients (N=128) aged ≥18 years diagnosed with type I or type II diabetes mellitus and VI due to DME in at least one eye and for whom treatment with RBZ was recommended by the physician, as per the French summary of product characteristics were included. The primary endpoint was the mean change in best-corrected visual acuity (BCVA) from baseline to M24 (letters). Key secondary endpoints included mean changes in BCVA at M12 and central retinal thickness (CRT) at M12 and M24; the proportion of patients with BCVA gain and loss of 5, 10, and 15 letters; treatment exposure; monitoring visits; concomitant treatments; and overall safety at M12 and M24. Here, we present the 12M results of the ETOILE study.

Results : The mean (±standard deviation [SD]) age of the patients was 65.4 (11.4) years with 58.7% being male, mean duration of DME was 1.0 (2.1) years, mean HbA_1c was 7.7% (1.2), and 76% of patients presented with bilateral DME. At baseline, the mean BCVA and CRT were 57.9 letters (95% confidence interval [CI]: 55.3;60.5) and 482.7 μm (95% CI: 458.0;507.5), respectively. Non-proliferative diabetic retinopathy was present in 74.4% of patients. Mean change in BCVA and CRT from baseline to M12 was 5.3 letters (95% CI: 2.0;8.7) and −112.8 μm (95% CI: -150.9;-74.7), respectively; 64.4% of patients gained and 13.7% lost ≥5 letters at M12 (Figure). Over 12M, the mean number of ranibizumab injections was 5.8 (2.5), and the mean number of visits was 8.2 (3.3). At least one treatment with focal and grid laser and pan-retinal photocoagulation was applied in 11.5% and 15.4% of patients, respectively; 10.6% of patients had at least one treatment switch during the 12M. No new safety findings were identified.

Conclusions : The 12M ETOILE study findings indicated that RBZ treatment under routine clinical practice led to vision improvement in treatment-naïve French patients with VI due to DME although some patients may have been undertreated. The safety profile of RBZ 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.