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

Autoři: Robin D. Hamilton aff001;  Andreas Clemens aff002;  Angelo Maria Minnella aff004;  Timothy Y. Y. Lai aff005;  Hong Dai aff006;  Taiji Sakamoto aff007;  Chui Ming Gemmy Cheung aff008;  Nor Fariza Ngah aff009;  Cornelia Dunger-Baldauf aff002;  Frank G. Holz aff010
Působiště autorů: Department of Medical Retina, Moorfields Eye Hospital NHS Foundation Trust and National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) at Moorfields Eye Hospital, London, United Kingdom aff001;  Medical Affairs Region Europe, Ophthalmology, Novartis Pharma AG, Basel, Switzerland aff002;  Department of Cardiology and Angiology I, Heart Center Freiburg University, Faculty of Medicine, University of Freiburg, Freiburg, Germany aff003;  Department of Ophthalmology, Catholic University of Sacred Hearth—Foundation “Policlinico Universitario A. Gemelli"—IRCCS, Rome, Italy aff004;  Department of Ophthalmology & Visual Sciences, The Chinese University of Hong Kong, Hong Kong Eye Hospital, Hong Kong SAR, China aff005;  Department of Ophthalmology, Beijing Hospital, National Center of Gerontology, Beijing, China aff006;  Department of Ophthalmology, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan aff007;  Singapore Eye Research Institute, Singapore National Eye Centre, Singapore aff008;  Hospital Shah Alam, Selangor, Malaysia aff009;  Department of Ophthalmology, University of Bonn, Bonn, Germany aff010
Vyšlo v časopise: PLoS ONE 15(1)
Kategorie: Research Article



To assess the 1-year effectiveness, safety, and treatment patterns of ranibizumab in patients with myopic choroidal neovascularization (mCNV) enrolled in the LUMINOUS study.


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-naïve 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.


Of the 297 mCNV patients recruited in the study, 108 were treatment-naïve 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-naïve and prior ranibizumab-treated groups, respectively. Most were Caucasian (treatment-naïve, 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-naïve 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-naïve 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.


Ranibizumab treatment for mCNV showed robust VA gains in treatment-naïve 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.

Klíčová slova:

Adverse events – Diabetic retinopathy – Eyes – Hemorrhage – Myopia – Retinal detachment – Vasculogenesis – Visual acuity


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