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197 - Evaluation du délai de rechute chez les patients naïfs de traitement atteints d’une DMLA lors du traitement par ranibizumab : résultats finaux à 24 mois de l’étude ORACLE

ORACLE is a real-life study to evaluate the time-to-disease onset 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 the final results from the ORACLE study.

ORACLE was a 24-month, prospective, multicenter, observational study carried out across 69centers in France. Treatment-naïve patients aged ≥55 years with nAMD and active choroidal neovascularization (CNV) were included. At each patient visit, the decision to administer ranibizumab 0.5 mg was at the investigator’s discretion. The primary objective was to assess the correlation between time-to-first and time-to-second recurrence of disease activity in enrolled patients with at least two recurrences over 24 months. Time-to-disease onset was defined as the time between the last ranibizumab injection and the next follow-up visit at which recurrent disease activity (defined by the physician based on visual acuity, spectral domain optical coherence tomography or fluorescein angiography) was diagnosed. Secondary outcomes included assessment of change in best-corrected visual acuity (BCVA), anatomical parameters, and treatment frequency. Adverse events (AEs) were recorded to assess the safety of ranibizumab.

Out of 742 treatment-naive patients screened between June 2014 and July 2015, 679 were analyzed in the study. The mean patients ‘age was 80.2 ±7.4 years and 66.9% were female. The mean (SD) time between diagnosis and first ranibizumab injection was 5.44 (8.49) days. At baseline, with regard to the type of CNV, 53% had occult, 30.7% classic and 16.3% minimally classic lesions. The mean central retinal thickness was 360.8 (113) μm. Among the patients with a full data set, 67 % experienced at least one recurrence at Year 1 and 78% at Year 2. A total of 241 patients had at least two recurrences. Among them, the median time-to-first and time-to-second new onset were 80 [72; 90] days and 83 [72; 90] days, respectively. The Pearson correlation coefficient [95% CI] between time-to-first and time-to-second disease onset was 0.137 [0.009; 0.260]. The two most frequent indicators of disease activity reported by investigators were the presence of intra-retinal fluid (83%) and an increase in central retinal thickness (26.6%) over 12 months. Baseline VA was 58.5 (16.5) ETDRS letters. At Month 3, mean (SD) visual activity increased by +5.8 (13.4) ETDRS letters from baseline, and by +4.0 (16.0) and +3.2 (19.0) ETDRS letters at Month 12 and 24, respectively.During the 24-month study period, the mean (SD) number of ranibizumab injections administered were 5.7 (2.2) and 2.4 injections (2.6) respectively for the first and for the second year. The median time between two injections was 48 days during Year 1 and 62 days during Year 2. The mean (SD) number of visits were 10.5 (2.0) and 5.9 (2.9) respectively for the first and for the second year.

The safety results were consistent with the well-characterized safety profile of ranibizumab.

In patients with at least two recurrences, the median time-to-first occurrence and time-to-second occurrence were similar in our study. These data might help to predict the need for retreatment with ranibizumab and to design individualized management of nAMD. The safety of ranibizumab was in line with its established profile.