Ranibizumab in patients with neovascular age‐related macular degeneration: results from the real‐world LUMINOUS ™ study

Purpose LUMINOUS(NCT01318941) was designed to evaluate the long‐term safety, effectiveness, and treatment patterns with ranibizumab 0.5 mg in clinical practice across all licensed indications. We report, the effectiveness and safety of ranibizumab treatment in patients with neovascular age‐related macular degeneration (nAMD) from the final analysis of LUMINOUS. Methods LUMINOUS is a recently‐completed, 5‐year, global, observational study. Consenting adult patients were treated as per the local ranibizumab label. Reported are the 1‐year visual acuity (VA, primary treated eye), and injection pattern for the treatment‐naïve nAMD patients. The incidence of adverse events (AEs) and serious AEs (SAEs) for the total treatment‐naïve nAMD cohort is also presented. Results Baseline and 1‐year VA data were available for 2701 treatment‐naïve nAMD patients. At baseline, the mean (SD) age was 75.9 (9.7) years, 58.4% were female, and 78.4% were Caucasian. VA (letters) gains at 1‐year in treatment‐naïve patients receiving <3, 3–6, and >6 injections were 2.1 (n = 372), 3.6 (n = 1499), and 4.3 (n = 830), from baseline of 45.0, 52.5, and 54.9, respectively. In all treatment‐naïve nAMD patients, the mean (SD) gain in VA of 3.6 (16.2) at 1 year from 52.2 (20.8) at baseline was achieved with a mean (SD) of 5.3 (2.7) ranibizumab injections and 9.3 (3.3) monitoring visits. Across all treatment‐naïve nAMD patients (n = 6241), the incidence of ocular/non‐ocular AEs and SAEs were 8.2%/12.8% and 0.9%/7.4%, respectively. Conclusions This analysis from LUMINOUS confirms the effectiveness of ranibizumab in treatment‐naïve nAMD, and shows a relationship between VA improvement and the number of ranibizumab injections each patient received.