Name

082 - Efficacité et tolérance du ranibizumab 0.5 mg chez des patients naïfs de traitement atteints de baisse visuelle due à un œdème maculaire diabétique en pratique médicale courante : résultats à 24 mois de l’étude ETOILE

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).

ETOILE is a multicenter (n=20), prospective, observational study. Treatment-naïve patients (N=106) aged ≥18 years diagnosed with type I or type II diabetes mellitus and VI due to DME and for whom treatment with RBZ was initiated, 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 change in BCVA from baseline to M12 and mean changes in central retinal thickness (CRT) from baseline to M12 and M24; the proportion of patients who gained or lost ≥ 5, ≥ 10, and  ≥ 15 letters; treatment exposure; monitoring visits; concomitant treatments; and overall safety at M12 and M24.

Here, we present the M 24 results of the ETOILE study.

The mean (±standard deviation [SD]) age of the patients was 65.4 (11.4) years with 59.4% being male, mean duration of DME was 1.0 (2.1) years, mean HbA1c was 7.7% (1.2), and 76% of patients presented with bilateral DME.

At baseline, the mean BCVA and CRT were 58.5 letters (95% confidence interval [CI]: 55.9;61.2) and 479 μm (95% CI: 454;504), respectively. Non-proliferative diabetic retinopathy was present in 75.3% of patients. Mean change in BCVA and CRT from baseline to M12 was 5.5 letters (95% CI: 2.5;8.4) and −111 μm (95% CI: -148;-74), respectively; 64% of patients gained and 13% lost ≥5 letters at M12. Visual gain is maintained at M24 with on average +6.3 letters change vs baseline (95% CI: 3.3;9.3) and slight improvement of retinal thickening was noticed over the second year with mean change in CRT of -147 μm vs baseline (95% CI: -184;-110).

The mean number of ranibizumab injections was 5.7 (2.5) during the first year of treatment and decreased with a mean of 1.9 (2.4) injections during the second year, 46.6% of patient receiving no ranibizumab treatment during the second year. In addition, the mean number of visits decreased after the first year, with 7.9 (3.4) visits in year 1 and 4.6 (3.6) visits in the second year. At least one treatment with focal and grid laser and pan-retinal photocoagulation was applied during the 2 years in 13.2% and 31.1% of patients, respectively. No new safety findings were identified.

The M24 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. Visual Improvement maintained at 2 years with fewer injections over the second year, although some patients may have been undertreated. The safety profile of RBZ was consistent with previously reported DME studies.