Combination verteporfin photodynamic therapy ranibizumab-dexamethasone in choroidal neovascularization due to age-related macular degeneration: results of a phase II randomized trial

Ron P Gallemore,1 Josh Wallsh,1 Henry L Hudson,2 Allen C Ho,3 Richard Chace,4 Joel Pearlman5 On behalf of the RADICAL Trial Group 1Retina Macula Institute, Torrance, CA, 2Retina Centers PC, Tucson, AZ, 3Wills Eye Institute, Philadelphia, PA, 4Eyesight Ophthalmic Services, Portsmouth, NH, 5Retinal...

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Autores principales:	Gallemore RP, Wallsh J, Hudson HL, Ho AC, Chace R, Pearlman J
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2017
Materias:	macular degeneration photodynamic therapy combination therapy ranibizumab Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/d886f12f5c434f90bb97c35a09fca955
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spelling	oai:doaj.org-article:d886f12f5c434f90bb97c35a09fca9552021-12-02T02:48:37ZCombination verteporfin photodynamic therapy ranibizumab-dexamethasone in choroidal neovascularization due to age-related macular degeneration: results of a phase II randomized trial1177-5483https://doaj.org/article/d886f12f5c434f90bb97c35a09fca9552017-01-01T00:00:00Zhttps://www.dovepress.com/combination-verteporfin-photodynamic-therapy-ranibizumab-dexamethasone-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Ron P Gallemore,1 Josh Wallsh,1 Henry L Hudson,2 Allen C Ho,3 Richard Chace,4 Joel Pearlman5 On behalf of the RADICAL Trial Group 1Retina Macula Institute, Torrance, CA, 2Retina Centers PC, Tucson, AZ, 3Wills Eye Institute, Philadelphia, PA, 4Eyesight Ophthalmic Services, Portsmouth, NH, 5Retinal Consultants Medical Group, Sacramento, CA, USA Purpose: To assess whether combination therapy (CT) reduces retreatments when compared to ranibizumab monotherapy (RM), while safely maintaining similar vision outcomes. Methods: In this 24-month trial, patients with age-related macular degeneration (AMD) were randomized to 1) quarter-fluence or 2) half-fluence triple therapy (verteporfin photodynamic therapy [vPDT] + ranibizumab + dexamethasone), 3) half-fluence double therapy (vPDT + ranibizumab), or 4) RM. The primary outcomes were number of retreatment visits and change from baseline in visual acuity (VA) at 12 months. Results: One hundred sixty-two subjects enrolled. There were 4.0 (P=0.02), 3.2 (P<0.001), 4.1 (P=0.03), and 5.7 retreatment visits through month 12, and 5.9 (P=0.03), 4.3 (P<0.001), 5.9 (P=0.02) and 8.7 through month 24, in groups 1, 2, 3, and 4, respectively (P-value comparing with RM). Month 12 VA score change from baseline (95% confidence interval) was +3.6 (–0.9 to +8.1), +6.8 (+2.4 to +11.1), +5.0 (+0.6 to +9.3), and +6.5 (+1.7 to +11.4), respectively. Conclusion: CT resulted in significantly fewer retreatment visits than a RM regimen at months 12 and 24. VA results appeared similar although wide confidence intervals preclude conclusions regarding vision outcomes. Keywords: age-related macular degeneration (AMD), combination therapy, ranibizumab, photodynamic therapy (PDT), verteporfinGallemore RPWallsh JHudson HLHo ACChace RPearlman JDove Medical Pressarticlemacular degenerationphotodynamic therapycombination therapyranibizumabOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 11, Pp 223-231 (2017)
institution	DOAJ
collection	DOAJ
language	EN
topic	macular degeneration photodynamic therapy combination therapy ranibizumab Ophthalmology RE1-994
spellingShingle	macular degeneration photodynamic therapy combination therapy ranibizumab Ophthalmology RE1-994 Gallemore RP Wallsh J Hudson HL Ho AC Chace R Pearlman J Combination verteporfin photodynamic therapy ranibizumab-dexamethasone in choroidal neovascularization due to age-related macular degeneration: results of a phase II randomized trial
description	Ron P Gallemore,1 Josh Wallsh,1 Henry L Hudson,2 Allen C Ho,3 Richard Chace,4 Joel Pearlman5 On behalf of the RADICAL Trial Group 1Retina Macula Institute, Torrance, CA, 2Retina Centers PC, Tucson, AZ, 3Wills Eye Institute, Philadelphia, PA, 4Eyesight Ophthalmic Services, Portsmouth, NH, 5Retinal Consultants Medical Group, Sacramento, CA, USA Purpose: To assess whether combination therapy (CT) reduces retreatments when compared to ranibizumab monotherapy (RM), while safely maintaining similar vision outcomes. Methods: In this 24-month trial, patients with age-related macular degeneration (AMD) were randomized to 1) quarter-fluence or 2) half-fluence triple therapy (verteporfin photodynamic therapy [vPDT] + ranibizumab + dexamethasone), 3) half-fluence double therapy (vPDT + ranibizumab), or 4) RM. The primary outcomes were number of retreatment visits and change from baseline in visual acuity (VA) at 12 months. Results: One hundred sixty-two subjects enrolled. There were 4.0 (P=0.02), 3.2 (P<0.001), 4.1 (P=0.03), and 5.7 retreatment visits through month 12, and 5.9 (P=0.03), 4.3 (P<0.001), 5.9 (P=0.02) and 8.7 through month 24, in groups 1, 2, 3, and 4, respectively (P-value comparing with RM). Month 12 VA score change from baseline (95% confidence interval) was +3.6 (–0.9 to +8.1), +6.8 (+2.4 to +11.1), +5.0 (+0.6 to +9.3), and +6.5 (+1.7 to +11.4), respectively. Conclusion: CT resulted in significantly fewer retreatment visits than a RM regimen at months 12 and 24. VA results appeared similar although wide confidence intervals preclude conclusions regarding vision outcomes. Keywords: age-related macular degeneration (AMD), combination therapy, ranibizumab, photodynamic therapy (PDT), verteporfin
format	article
author	Gallemore RP Wallsh J Hudson HL Ho AC Chace R Pearlman J
author_facet	Gallemore RP Wallsh J Hudson HL Ho AC Chace R Pearlman J
author_sort	Gallemore RP
title	Combination verteporfin photodynamic therapy ranibizumab-dexamethasone in choroidal neovascularization due to age-related macular degeneration: results of a phase II randomized trial
title_short	Combination verteporfin photodynamic therapy ranibizumab-dexamethasone in choroidal neovascularization due to age-related macular degeneration: results of a phase II randomized trial
title_full	Combination verteporfin photodynamic therapy ranibizumab-dexamethasone in choroidal neovascularization due to age-related macular degeneration: results of a phase II randomized trial
title_fullStr	Combination verteporfin photodynamic therapy ranibizumab-dexamethasone in choroidal neovascularization due to age-related macular degeneration: results of a phase II randomized trial
title_full_unstemmed	Combination verteporfin photodynamic therapy ranibizumab-dexamethasone in choroidal neovascularization due to age-related macular degeneration: results of a phase II randomized trial
title_sort	combination verteporfin photodynamic therapy ranibizumab-dexamethasone in choroidal neovascularization due to age-related macular degeneration: results of a phase ii randomized trial
publisher	Dove Medical Press
publishDate	2017
url	https://doaj.org/article/d886f12f5c434f90bb97c35a09fca955
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Combination verteporfin photodynamic therapy ranibizumab-dexamethasone in choroidal neovascularization due to age-related macular degeneration: results of a phase II randomized trial

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