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

Hamilton RD 1 , Clemens A 2 , Minnella AM 3 , Lai TYY 4 , Dai H 5 , Sakamoto T 6 Show all authors , Gemmy Cheung CM 7 , Ngah NF 8 , Dunger-Baldauf C 2 , Holz FG 9 , LUMINOUS study group

Affiliations 

  • 1 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
  • 2 Medical Affairs Region Europe, Ophthalmology, Novartis Pharma AG, Basel, Switzerland
  • 3 Department of Ophthalmology, Catholic University of Sacred Hearth-Foundation "Policlinico Universitario A. Gemelli"-IRCCS, Rome, Italy
  • 4 Department of Ophthalmology & Visual Sciences, The Chinese University of Hong Kong, Hong Kong Eye Hospital, Hong Kong SAR, China
  • 5 Department of Ophthalmology, Beijing Hospital, National Center of Gerontology, Beijing, China
  • 6 Department of Ophthalmology, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan
  • 7 Singapore Eye Research Institute, Singapore National Eye Centre, Singapore
  • 8 Hospital Shah Alam, Selangor, Malaysia
  • 9 Department of Ophthalmology, University of Bonn, Bonn, Germany
PLoS One, 2020;15(1):e0227557.
PMID: 31961888 DOI: 10.1371/journal.pone.0227557

Abstract

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-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.

RESULTS: 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.

CONCLUSIONS: 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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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