A prospective pilot study comparing combined intravitreal ranibizumab and half-fluence photodynamic therapy with ranibizumab monotherapy in the treatment of neovascular age-related macular degeneration

Patrick D Williams,1 David Callanan,1 Wayne Solley,1 Robert L Avery,2 Dante J Pieramici,2 Tom Aaberg31Texas Retina Associates, Dallas, TX, 2California Retina Consultants and Research Foundation, Santa Barbara, CA, 3Retinal Associates, Grand Rapids, MI, USAPurpose: This prospective multi-center pilot...

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Main Authors: Williams PD, Callanan D, Solley W, Avery RL, Pieramici DJ, Aaberg T
Format: Article
Language:English
Published: Dove Medical Press 2012-09-01
Series:Clinical Ophthalmology
Online Access:http://www.dovepress.com/a-prospective-pilot-study-comparing-combined-intravitreal-ranibizumab--a11025
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author Williams PD
Callanan D
Solley W
Avery RL
Pieramici DJ
Aaberg T
author_facet Williams PD
Callanan D
Solley W
Avery RL
Pieramici DJ
Aaberg T
author_sort Williams PD
collection DOAJ
description Patrick D Williams,1 David Callanan,1 Wayne Solley,1 Robert L Avery,2 Dante J Pieramici,2 Tom Aaberg31Texas Retina Associates, Dallas, TX, 2California Retina Consultants and Research Foundation, Santa Barbara, CA, 3Retinal Associates, Grand Rapids, MI, USAPurpose: This prospective multi-center pilot study compares the use of half-fluence photodynamic therapy combined with ranibizumab with ranibizumab monotherapy for the treatment of neovascular age-related macular degeneration.Methods: All patients presenting with untreated subfoveal neovascular age-related macular degeneration were considered for inclusion. Patients were randomized to receive either ranibizumab with half-fluence photodynamic therapy or ranibizumab alone. Patients in the ranibizumab alone group were given three consecutive monthly ranibizumab injections and were followed monthly. They were treated with ranibizumab as needed, based on clinical discretion, using vision and optical coherence tomography. Patients in the combined group were given one same-day combined ranibizumab and half-fluence (25 j/cm2) photodynamic therapy treatment and were treated monthly as needed. Outcomes included changes in standardized visual acuity, optical coherence tomography foveal thickness, and percentage of as-needed injections to maintenance examinations.Results: Fifty-six out of 60 enrolled patients completed the twelve month primary outcome visit; this consisted of 27 patients receiving ranibizumab alone and 29 receiving combined treatment. The average age was 79.1 for the ranibizumab alone group and 79.3 for the combined group. The mean visual acuity in the ranibizumab alone group improved from 52.9 Early Treatment of Diabetic Retinopathy letters initially to 62.8 letters at twelve months. The mean visual acuity in the combined group improved from 49.2 letters to 51.8 letters at twelve months. The differences in visual acuity improvements were not statistically significant based on a two-tailed t-test (P = 0.2). Due to the presence of outliers in each group, a Mann–Whitney U test was performed to confirm the results (U = 325; P = 0.28). The mean optical coherence tomography foveal thickness improved 92.5 microns and 106.7 microns in the ranibizumab alone and the combined group, respectively. The difference was not significant based on a two-tailed t-test (P = 0.6). The ranibizumab alone group received an average of 6.8 injections, while the combined group received an average of three injections. This difference was not significant based on a chi-square test (P = 0.11).Conclusion: The groups appeared similar based on statistical analysis, but larger studies are needed to determine possible small differences between combination therapy and monotherapy.Keywords: ranibizumab, macular degeneration, photodynamic therapy, verteporfin, choroidal neovascularization, anti-vegf
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spelling doaj.art-69984e425b7a47b6ba137c37993e58b42022-12-21T21:46:08ZengDove Medical PressClinical Ophthalmology1177-54671177-54832012-09-012012default15191525A prospective pilot study comparing combined intravitreal ranibizumab and half-fluence photodynamic therapy with ranibizumab monotherapy in the treatment of neovascular age-related macular degenerationWilliams PDCallanan DSolley WAvery RLPieramici DJAaberg TPatrick D Williams,1 David Callanan,1 Wayne Solley,1 Robert L Avery,2 Dante J Pieramici,2 Tom Aaberg31Texas Retina Associates, Dallas, TX, 2California Retina Consultants and Research Foundation, Santa Barbara, CA, 3Retinal Associates, Grand Rapids, MI, USAPurpose: This prospective multi-center pilot study compares the use of half-fluence photodynamic therapy combined with ranibizumab with ranibizumab monotherapy for the treatment of neovascular age-related macular degeneration.Methods: All patients presenting with untreated subfoveal neovascular age-related macular degeneration were considered for inclusion. Patients were randomized to receive either ranibizumab with half-fluence photodynamic therapy or ranibizumab alone. Patients in the ranibizumab alone group were given three consecutive monthly ranibizumab injections and were followed monthly. They were treated with ranibizumab as needed, based on clinical discretion, using vision and optical coherence tomography. Patients in the combined group were given one same-day combined ranibizumab and half-fluence (25 j/cm2) photodynamic therapy treatment and were treated monthly as needed. Outcomes included changes in standardized visual acuity, optical coherence tomography foveal thickness, and percentage of as-needed injections to maintenance examinations.Results: Fifty-six out of 60 enrolled patients completed the twelve month primary outcome visit; this consisted of 27 patients receiving ranibizumab alone and 29 receiving combined treatment. The average age was 79.1 for the ranibizumab alone group and 79.3 for the combined group. The mean visual acuity in the ranibizumab alone group improved from 52.9 Early Treatment of Diabetic Retinopathy letters initially to 62.8 letters at twelve months. The mean visual acuity in the combined group improved from 49.2 letters to 51.8 letters at twelve months. The differences in visual acuity improvements were not statistically significant based on a two-tailed t-test (P = 0.2). Due to the presence of outliers in each group, a Mann–Whitney U test was performed to confirm the results (U = 325; P = 0.28). The mean optical coherence tomography foveal thickness improved 92.5 microns and 106.7 microns in the ranibizumab alone and the combined group, respectively. The difference was not significant based on a two-tailed t-test (P = 0.6). The ranibizumab alone group received an average of 6.8 injections, while the combined group received an average of three injections. This difference was not significant based on a chi-square test (P = 0.11).Conclusion: The groups appeared similar based on statistical analysis, but larger studies are needed to determine possible small differences between combination therapy and monotherapy.Keywords: ranibizumab, macular degeneration, photodynamic therapy, verteporfin, choroidal neovascularization, anti-vegfhttp://www.dovepress.com/a-prospective-pilot-study-comparing-combined-intravitreal-ranibizumab--a11025
spellingShingle Williams PD
Callanan D
Solley W
Avery RL
Pieramici DJ
Aaberg T
A prospective pilot study comparing combined intravitreal ranibizumab and half-fluence photodynamic therapy with ranibizumab monotherapy in the treatment of neovascular age-related macular degeneration
Clinical Ophthalmology
title A prospective pilot study comparing combined intravitreal ranibizumab and half-fluence photodynamic therapy with ranibizumab monotherapy in the treatment of neovascular age-related macular degeneration
title_full A prospective pilot study comparing combined intravitreal ranibizumab and half-fluence photodynamic therapy with ranibizumab monotherapy in the treatment of neovascular age-related macular degeneration
title_fullStr A prospective pilot study comparing combined intravitreal ranibizumab and half-fluence photodynamic therapy with ranibizumab monotherapy in the treatment of neovascular age-related macular degeneration
title_full_unstemmed A prospective pilot study comparing combined intravitreal ranibizumab and half-fluence photodynamic therapy with ranibizumab monotherapy in the treatment of neovascular age-related macular degeneration
title_short A prospective pilot study comparing combined intravitreal ranibizumab and half-fluence photodynamic therapy with ranibizumab monotherapy in the treatment of neovascular age-related macular degeneration
title_sort prospective pilot study comparing combined intravitreal ranibizumab and half fluence photodynamic therapy with ranibizumab monotherapy in the treatment of neovascular age related macular degeneration
url http://www.dovepress.com/a-prospective-pilot-study-comparing-combined-intravitreal-ranibizumab--a11025
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