Real-world effectiveness and safety of ranibizumab for the treatment of myopic choroidal neovascularization: Results from the LUMINOUS study

Purpose To assess the 1-year effectiveness, safety, and treatment patterns of ranibizumab in patients with myopic choroidal neovascularization (mCNV) enrolled in the LUMINOUS study. Methods This 5-year, prospective, multicenter, observational, study enrolled 30,138 patients across all approved ranibizumab indications from outpatient ophthalmology clinics. 297 consenting patients (.18 years) with mCNV who were treatment-naive or prior-treated with ranibizumab or other ocular treatments were enrolled, and treated with ranibizumab according to the local product label. The main outcomes are visual acuity (VA; Early Treatment Diabetic Retinopathy Study letters or equivalent), adverse events during the study, and treatment exposure over 1 year. Results are presented by prior treatment status of the study eye and injection frequency. Results Of the 297 mCNV patients recruited in the study, 108 were treatment-naive and 175 were prior ranibizumab-treated. At baseline, the mean age of patients was 57.6 years, and 59.0 years and 80.6% and 65.7% were female in the treatment-naive and prior ranibizumab-treated groups, respectively. Most were Caucasian (treatment-naive, 88.9%; prior ranibizumab-treated, 86.9%). The mean (+/- standard deviation [SD]) VA letter changes to 1 year were +9.7 (+/- 17.99) from 49.5 (+/- 20.51) and +1.5 (+/- 13.15) from 58.5 (+/- 19.79) and these were achieved with a mean (SD) of 3.0 (+/- 1.58) and 2.6 (+/- 2.33) injections in the treatment-naive and prior ranibizumab-treated groups, respectively. Presented by injection frequencies 1-2, 3-4 and.5 injections in Year 1, the mean (SD) VA changes were +15.0 (+/- 14.70), +7.7 (+/- 19.91) and - 0.7 (+/- 16.05) in treatment-naive patients and +1.5 (+/- 14.57), +3.1 (+/- 11.53) and -3.6 (+/- 11.97) in prior ranibizumab-treated patients, respectively. The safety profile was comparable with previous ranibizumab studies. Conclusions Ranibizumab treatment for mCNV showed robust VA gains in treatment-naive patients and VA maintenance in prior ranibizumab-treated patients in a clinical practice setting, consisting mainly of Caucasians. No new safety signals were observed during the study.