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Evaluation du délai de de rechute chez les patients naïfs de traitement atteints d’une DMLA lors du traitement par ranibizumab: Résultats à 12 mois de l’étude ORACLE

ORACLE is a real-life study to evaluate the time-to-recurrence of disease activity in newly diagnosed treatment-naïve patients with neovascular age-related macular degeneration (nAMD) treated with ranibizumab over a maximum of 24 months. Here we present the12-month results from the ORACLE study

A 24-month, prospective, multicenter, observational study carried out across 69 centers in France. Treatment-naïve patients with nAMD aged ≥55 years and active choroidal neovascularization were included. Patients received ranibizumab 0.5 mg with decision of monitoring and/or injections visit at the investigator’s discretion. The primary objective was to assess the correlation between time-to-1st and time-to-2nd recurrence of disease activity in enrolled patients with at least a 2nd recurrence over 24 months. Time to recurrence is defined as the time between the last ranibizumab injection and next follow-up visit at which recurrent disease activity is diagnosed. Secondary outcomes include assessment of change in best-corrected visual acuity (BCVA), anatomical parameters, and treatment frequency at different time points. Adverse events (AEs) were recorded to assess the safety of ranibizumab.

Overall, 742 patients were enrolled in the study. The results for efficacy assessment are for the reference population (n=690) unless otherwise stated. The mean (SD) time-to-1st and time-to-2nd recurrence were 107.1 (65.8; n=366) and 85.4 (42.6; n=159) days, respectively. The mean (SD) change in BCVA at Month 3 and Month 12 was 5.62 (13.6) and 4.10 (16.3) ETDRS letters respectively. At Month 12, the mean change (SD) in central retinal thickness was −83.79 (123.98) μm. At Month 12, 71.7% (n=403) and 70.1% (n=394) patients had absence of intraretinal and subretinal fluid respectively. The mean number of injections was 5.7 and the mean time (SD) between 2 injections was 52.9 (26.6) days. No new safety findings were identified.

When completed at 24 months, this study will provide valuable data that might help to predict the need for retreatment with ranibizumab

The results of this study might help to design individualized management of nAMD. Safety of ranibizumab was in line with its established profile.