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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 ran...

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Autores principales: Hamilton, Robin D., Clemens, Andreas, Minnella, Angelo Maria, Lai, Timothy Y. Y., Dai, Hong, Sakamoto, Taiji, Gemmy Cheung, Chui Ming, Ngah, Nor Fariza, Dunger-Baldauf, Cornelia, Holz, Frank G.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6974143/
https://www.ncbi.nlm.nih.gov/pubmed/31961888
http://dx.doi.org/10.1371/journal.pone.0227557
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author Hamilton, Robin D.
Clemens, Andreas
Minnella, Angelo Maria
Lai, Timothy Y. Y.
Dai, Hong
Sakamoto, Taiji
Gemmy Cheung, Chui Ming
Ngah, Nor Fariza
Dunger-Baldauf, Cornelia
Holz, Frank G.
author_facet Hamilton, Robin D.
Clemens, Andreas
Minnella, Angelo Maria
Lai, Timothy Y. Y.
Dai, Hong
Sakamoto, Taiji
Gemmy Cheung, Chui Ming
Ngah, Nor Fariza
Dunger-Baldauf, Cornelia
Holz, Frank G.
author_sort Hamilton, Robin D.
collection PubMed
description 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.
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spelling pubmed-69741432020-02-04 Real-world effectiveness and safety of ranibizumab for the treatment of myopic choroidal neovascularization: Results from the LUMINOUS study Hamilton, Robin D. Clemens, Andreas Minnella, Angelo Maria Lai, Timothy Y. Y. Dai, Hong Sakamoto, Taiji Gemmy Cheung, Chui Ming Ngah, Nor Fariza Dunger-Baldauf, Cornelia Holz, Frank G. PLoS One Research Article 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. Public Library of Science 2020-01-21 /pmc/articles/PMC6974143/ /pubmed/31961888 http://dx.doi.org/10.1371/journal.pone.0227557 Text en © 2020 Hamilton et al http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Hamilton, Robin D.
Clemens, Andreas
Minnella, Angelo Maria
Lai, Timothy Y. Y.
Dai, Hong
Sakamoto, Taiji
Gemmy Cheung, Chui Ming
Ngah, Nor Fariza
Dunger-Baldauf, Cornelia
Holz, Frank G.
Real-world effectiveness and safety of ranibizumab for the treatment of myopic choroidal neovascularization: Results from the LUMINOUS study
title Real-world effectiveness and safety of ranibizumab for the treatment of myopic choroidal neovascularization: Results from the LUMINOUS study
title_full Real-world effectiveness and safety of ranibizumab for the treatment of myopic choroidal neovascularization: Results from the LUMINOUS study
title_fullStr Real-world effectiveness and safety of ranibizumab for the treatment of myopic choroidal neovascularization: Results from the LUMINOUS study
title_full_unstemmed Real-world effectiveness and safety of ranibizumab for the treatment of myopic choroidal neovascularization: Results from the LUMINOUS study
title_short Real-world effectiveness and safety of ranibizumab for the treatment of myopic choroidal neovascularization: Results from the LUMINOUS study
title_sort real-world effectiveness and safety of ranibizumab for the treatment of myopic choroidal neovascularization: results from the luminous study
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6974143/
https://www.ncbi.nlm.nih.gov/pubmed/31961888
http://dx.doi.org/10.1371/journal.pone.0227557
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