Baseline visual acuity strongly predicts visual acuity gain in patients with diabetic macular edema following anti-vascular endothelial growth factor treatment across trials

Pravin U Dugel,1,2 Jost Hillenkamp,3 Sobha Sivaprasad,4,5 Jessica Vögeler,6 Marie-Catherine Mousseau,7 Andreas Wenzel,8 Philippe Margaron,8 Ron Hashmonay,8 Pascale Massin9 1Retinal Consultants of Arizona LTD, Retinal Research Institute LLC, Phoenix, AZ, 2USC Eye Institute, Keck School of M...

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Autores principales:	Dugel PU, Hillenkamp J, Sivaprasad S, Vögeler J, Mousseau MC, Wenzel A, Margaron P, Hashmonay R, Massin P
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2016
Materias:	aflibercept anti-vascular endothelial growth factor best corrected visual acuity cross-trial comparison diabetic macular edema ranibizumab. Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/550d47124ce14593bb3a56025934ce30
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spelling	oai:doaj.org-article:550d47124ce14593bb3a56025934ce302021-12-02T00:38:50ZBaseline visual acuity strongly predicts visual acuity gain in patients with diabetic macular edema following anti-vascular endothelial growth factor treatment across trials1177-5483https://doaj.org/article/550d47124ce14593bb3a56025934ce302016-06-01T00:00:00Zhttps://www.dovepress.com/baseline-visual-acuity-strongly-predicts-visual-acuity-gain-in-patient-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Pravin U Dugel,1,2 Jost Hillenkamp,3 Sobha Sivaprasad,4,5 Jessica Vögeler,6 Marie-Catherine Mousseau,7 Andreas Wenzel,8 Philippe Margaron,8 Ron Hashmonay,8 Pascale Massin9 1Retinal Consultants of Arizona LTD, Retinal Research Institute LLC, Phoenix, AZ, 2USC Eye Institute, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; 3Department of Ophthalmology, Julius-Maximilians University, Würzburg, Germany; 4NIHR Biomedical Research Centre, Moorfields Eye Hospital, London, 5King’s College Hospital, London, UK; 6Novartis Pharma GmbH, Nürnberg, Germany; 7Novartis Ireland Limited, Dublin, Ireland; 8Novartis Pharma AG, Basel, Switzerland; 9Department of Ophthalmology, Hôpital Lariboisière, Assistance Publique des Hôpitaux de Paris, Université Paris Diderot, Paris, France Objective: This study was designed to evaluate the correlation of baseline visual acuity (VA) with VA outcome in response to anti-vascular endothelial growth factor (VEGF) in diabetic macular edema using a retrospective analysis of nine clinical trials. The result will help assess the relevance of VA gain comparisons across trials. Methods: A correlation analysis was performed between mean baseline VA and VA gain at month 12 for 1,616 diabetic macular edema patients across nine randomized clinical trials (RESOLVE, RISE, RIDE, RESTORE, RETAIN, DRCR.net Protocol I, DA VINCI, VIVID, VISTA) with anti-VEGF treatment regimens ranibizumab 0.5 mg and aflibercept 2 mg. Results: The mean baseline VA ranged from 56.9 to 64.8 Early Treatment Diabetic Retinopathy Study (ETDRS) letters. The mean VA gain at month 12 ranged from 6.8 to 13.1 ETDRS letters across trials. There was a strong inverse correlation between mean baseline VA and VA gain at month 12 (r=-0.85). The mean VA at 12 months plateaued at ~70 (68.5–73.0) ETDRS letters (20/40 Snellen VA equivalent) for the anti-VEGF treatment groups from all trials, regardless of dosing regimens and agents. Conclusion: Cross-trial comparisons based on changes in best-corrected visual acuity should be done cautiously and only after adjusting for best-corrected visual acuity at baseline. Furthermore, the total VA afforded by treatment appears to be subject to a plateau effect, which warrants further exploration. Keywords: aflibercept, anti-vascular endothelial growth factor, best-corrected visual acuity, cross-trial comparison, diabetic macular edema, ranibizumabDugel PUHillenkamp JSivaprasad SVögeler JMousseau MCWenzel AMargaron PHashmonay RMassin PDove Medical Pressarticleafliberceptanti-vascular endothelial growth factorbest corrected visual acuitycross-trial comparisondiabetic macular edemaranibizumab.OphthalmologyRE1-994ENClinical Ophthalmology, Vol 2016, Iss Issue 1, Pp 1103-1110 (2016)
institution	DOAJ
collection	DOAJ
language	EN
topic	aflibercept anti-vascular endothelial growth factor best corrected visual acuity cross-trial comparison diabetic macular edema ranibizumab. Ophthalmology RE1-994
spellingShingle	aflibercept anti-vascular endothelial growth factor best corrected visual acuity cross-trial comparison diabetic macular edema ranibizumab. Ophthalmology RE1-994 Dugel PU Hillenkamp J Sivaprasad S Vögeler J Mousseau MC Wenzel A Margaron P Hashmonay R Massin P Baseline visual acuity strongly predicts visual acuity gain in patients with diabetic macular edema following anti-vascular endothelial growth factor treatment across trials
description	Pravin U Dugel,1,2 Jost Hillenkamp,3 Sobha Sivaprasad,4,5 Jessica Vögeler,6 Marie-Catherine Mousseau,7 Andreas Wenzel,8 Philippe Margaron,8 Ron Hashmonay,8 Pascale Massin9 1Retinal Consultants of Arizona LTD, Retinal Research Institute LLC, Phoenix, AZ, 2USC Eye Institute, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; 3Department of Ophthalmology, Julius-Maximilians University, Würzburg, Germany; 4NIHR Biomedical Research Centre, Moorfields Eye Hospital, London, 5King’s College Hospital, London, UK; 6Novartis Pharma GmbH, Nürnberg, Germany; 7Novartis Ireland Limited, Dublin, Ireland; 8Novartis Pharma AG, Basel, Switzerland; 9Department of Ophthalmology, Hôpital Lariboisière, Assistance Publique des Hôpitaux de Paris, Université Paris Diderot, Paris, France Objective: This study was designed to evaluate the correlation of baseline visual acuity (VA) with VA outcome in response to anti-vascular endothelial growth factor (VEGF) in diabetic macular edema using a retrospective analysis of nine clinical trials. The result will help assess the relevance of VA gain comparisons across trials. Methods: A correlation analysis was performed between mean baseline VA and VA gain at month 12 for 1,616 diabetic macular edema patients across nine randomized clinical trials (RESOLVE, RISE, RIDE, RESTORE, RETAIN, DRCR.net Protocol I, DA VINCI, VIVID, VISTA) with anti-VEGF treatment regimens ranibizumab 0.5 mg and aflibercept 2 mg. Results: The mean baseline VA ranged from 56.9 to 64.8 Early Treatment Diabetic Retinopathy Study (ETDRS) letters. The mean VA gain at month 12 ranged from 6.8 to 13.1 ETDRS letters across trials. There was a strong inverse correlation between mean baseline VA and VA gain at month 12 (r=-0.85). The mean VA at 12 months plateaued at ~70 (68.5–73.0) ETDRS letters (20/40 Snellen VA equivalent) for the anti-VEGF treatment groups from all trials, regardless of dosing regimens and agents. Conclusion: Cross-trial comparisons based on changes in best-corrected visual acuity should be done cautiously and only after adjusting for best-corrected visual acuity at baseline. Furthermore, the total VA afforded by treatment appears to be subject to a plateau effect, which warrants further exploration. Keywords: aflibercept, anti-vascular endothelial growth factor, best-corrected visual acuity, cross-trial comparison, diabetic macular edema, ranibizumab
format	article
author	Dugel PU Hillenkamp J Sivaprasad S Vögeler J Mousseau MC Wenzel A Margaron P Hashmonay R Massin P
author_facet	Dugel PU Hillenkamp J Sivaprasad S Vögeler J Mousseau MC Wenzel A Margaron P Hashmonay R Massin P
author_sort	Dugel PU
title	Baseline visual acuity strongly predicts visual acuity gain in patients with diabetic macular edema following anti-vascular endothelial growth factor treatment across trials
title_short	Baseline visual acuity strongly predicts visual acuity gain in patients with diabetic macular edema following anti-vascular endothelial growth factor treatment across trials
title_full	Baseline visual acuity strongly predicts visual acuity gain in patients with diabetic macular edema following anti-vascular endothelial growth factor treatment across trials
title_fullStr	Baseline visual acuity strongly predicts visual acuity gain in patients with diabetic macular edema following anti-vascular endothelial growth factor treatment across trials
title_full_unstemmed	Baseline visual acuity strongly predicts visual acuity gain in patients with diabetic macular edema following anti-vascular endothelial growth factor treatment across trials
title_sort	baseline visual acuity strongly predicts visual acuity gain in patients with diabetic macular edema following anti-vascular endothelial growth factor treatment across trials
publisher	Dove Medical Press
publishDate	2016
url	https://doaj.org/article/550d47124ce14593bb3a56025934ce30
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Baseline visual acuity strongly predicts visual acuity gain in patients with diabetic macular edema following anti-vascular endothelial growth factor treatment across trials

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