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Influence of Ranibizumab versus laser photocoagulation on radiation retinopathy (RadiRet) - a prospective randomized controlled trial

PURPOSE: To demonstrate superiority of intravitreal ranibizumab 0.5 mg compared to focal and peripheral laser treatment in patients with radiation retinopathy for choroidal melanoma. METHODS: Inclusion criteria were as follows: patients with radiation retinopathy and visual acuity impairment due to...

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Autores principales: Seibel, Ira, Vollhardt, Daniela, Riechardt, Aline I., Rehak, Matus, Schmied, Sabine, Schiller, Petra, Zeitz, Oliver, Hellmich, Martin, Joussen, Antonia M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7575494/
https://www.ncbi.nlm.nih.gov/pubmed/32112140
http://dx.doi.org/10.1007/s00417-020-04618-7
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author Seibel, Ira
Vollhardt, Daniela
Riechardt, Aline I.
Rehak, Matus
Schmied, Sabine
Schiller, Petra
Zeitz, Oliver
Hellmich, Martin
Joussen, Antonia M.
author_facet Seibel, Ira
Vollhardt, Daniela
Riechardt, Aline I.
Rehak, Matus
Schmied, Sabine
Schiller, Petra
Zeitz, Oliver
Hellmich, Martin
Joussen, Antonia M.
author_sort Seibel, Ira
collection PubMed
description PURPOSE: To demonstrate superiority of intravitreal ranibizumab 0.5 mg compared to focal and peripheral laser treatment in patients with radiation retinopathy for choroidal melanoma. METHODS: Inclusion criteria were as follows: patients with radiation retinopathy and visual acuity impairment due to radiation maculopathy accessible for laser therapy, age ≥ 18 years, and BCVA less than 20/32. The main objective was to study the change in best-corrected visual acuity (BCVA) over 6 months from ranibizumab 0.5 mg (experimental) compared to focal laser of the macula and panretinal laser treatment of the ischemic retina (control) in patients with radiation retinopathy in choroidal melanoma. The secondary objectives of the radiation retinopathy study were to compare functional and anatomical results between ranibizumab and laser group over 12 months and to measure the frequency of vitreous hemorrhage and rubeosis iridis. RESULTS: The intention-to-treat analysis included 31 patients assigned to ranibizumab (n = 15) or laser treatment (n = 16). In terms of BCVA at month 6, ranibizumab was superior to laser treatment, with an advantage of 0.14 logMAR, 95% CI 0.01 to 0.25, p = 0.030. The positive effect of ranibizumab disappeared after treatment was discontinued. Similar results without statistically significant difference were found with respect to macular thickness. In both groups, no change was observed at month 6 in the size of ischemia in the macula or periphery compared to baseline. There was 1 case of vitreous hemorrhage in the laser group and no case of rubeosis iridis over time. CONCLUSIONS: This study showed a statistically significant improvement in visual acuity and clear superiority of ranibizumab compared to laser treatment up to 26 weeks, but this effect disappeared at week 52 after completion of intravitreal treatment. Ranibizumab and PRP are considered equivalent in terms of the non-appearance of proliferative radiation retinopathy during the study. TRIAL REGISTRATION: EudraCT Number: 2011-004463-69 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s00417-020-04618-7) contains supplementary material, which is available to authorized users.
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spelling pubmed-75754942020-10-21 Influence of Ranibizumab versus laser photocoagulation on radiation retinopathy (RadiRet) - a prospective randomized controlled trial Seibel, Ira Vollhardt, Daniela Riechardt, Aline I. Rehak, Matus Schmied, Sabine Schiller, Petra Zeitz, Oliver Hellmich, Martin Joussen, Antonia M. Graefes Arch Clin Exp Ophthalmol Oncology PURPOSE: To demonstrate superiority of intravitreal ranibizumab 0.5 mg compared to focal and peripheral laser treatment in patients with radiation retinopathy for choroidal melanoma. METHODS: Inclusion criteria were as follows: patients with radiation retinopathy and visual acuity impairment due to radiation maculopathy accessible for laser therapy, age ≥ 18 years, and BCVA less than 20/32. The main objective was to study the change in best-corrected visual acuity (BCVA) over 6 months from ranibizumab 0.5 mg (experimental) compared to focal laser of the macula and panretinal laser treatment of the ischemic retina (control) in patients with radiation retinopathy in choroidal melanoma. The secondary objectives of the radiation retinopathy study were to compare functional and anatomical results between ranibizumab and laser group over 12 months and to measure the frequency of vitreous hemorrhage and rubeosis iridis. RESULTS: The intention-to-treat analysis included 31 patients assigned to ranibizumab (n = 15) or laser treatment (n = 16). In terms of BCVA at month 6, ranibizumab was superior to laser treatment, with an advantage of 0.14 logMAR, 95% CI 0.01 to 0.25, p = 0.030. The positive effect of ranibizumab disappeared after treatment was discontinued. Similar results without statistically significant difference were found with respect to macular thickness. In both groups, no change was observed at month 6 in the size of ischemia in the macula or periphery compared to baseline. There was 1 case of vitreous hemorrhage in the laser group and no case of rubeosis iridis over time. CONCLUSIONS: This study showed a statistically significant improvement in visual acuity and clear superiority of ranibizumab compared to laser treatment up to 26 weeks, but this effect disappeared at week 52 after completion of intravitreal treatment. Ranibizumab and PRP are considered equivalent in terms of the non-appearance of proliferative radiation retinopathy during the study. TRIAL REGISTRATION: EudraCT Number: 2011-004463-69 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s00417-020-04618-7) contains supplementary material, which is available to authorized users. Springer Berlin Heidelberg 2020-02-28 2020 /pmc/articles/PMC7575494/ /pubmed/32112140 http://dx.doi.org/10.1007/s00417-020-04618-7 Text en © The Author(s) 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
spellingShingle Oncology
Seibel, Ira
Vollhardt, Daniela
Riechardt, Aline I.
Rehak, Matus
Schmied, Sabine
Schiller, Petra
Zeitz, Oliver
Hellmich, Martin
Joussen, Antonia M.
Influence of Ranibizumab versus laser photocoagulation on radiation retinopathy (RadiRet) - a prospective randomized controlled trial
title Influence of Ranibizumab versus laser photocoagulation on radiation retinopathy (RadiRet) - a prospective randomized controlled trial
title_full Influence of Ranibizumab versus laser photocoagulation on radiation retinopathy (RadiRet) - a prospective randomized controlled trial
title_fullStr Influence of Ranibizumab versus laser photocoagulation on radiation retinopathy (RadiRet) - a prospective randomized controlled trial
title_full_unstemmed Influence of Ranibizumab versus laser photocoagulation on radiation retinopathy (RadiRet) - a prospective randomized controlled trial
title_short Influence of Ranibizumab versus laser photocoagulation on radiation retinopathy (RadiRet) - a prospective randomized controlled trial
title_sort influence of ranibizumab versus laser photocoagulation on radiation retinopathy (radiret) - a prospective randomized controlled trial
topic Oncology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7575494/
https://www.ncbi.nlm.nih.gov/pubmed/32112140
http://dx.doi.org/10.1007/s00417-020-04618-7
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