The clinical utility of aflibercept for diabetic macular edema

Michael W StewartDepartment of Ophthalmology, Mayo School of Medicine, Jacksonville, FL, USAAbstract: The treatment of center-involving diabetic macular edema (DME) has improved because of the proven efficacy of drugs that inhibit the effects of vascular endothelial growth factor (VEGF). The newest...

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Main Author: Stewart MW
Format: Article
Language:English
Published: Dove Medical Press 2015-09-01
Series:Diabetes, Metabolic Syndrome and Obesity : Targets and Therapy
Online Access:https://www.dovepress.com/the-clinical-utility-of-aflibercept-for-diabetic-macular-edema-peer-reviewed-article-DMSO
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spelling doaj-858c1642809b40a2ac5ad0401170055d2020-11-25T01:02:23ZengDove Medical PressDiabetes, Metabolic Syndrome and Obesity : Targets and Therapy1178-70072015-09-012015default47348223740The clinical utility of aflibercept for diabetic macular edemaStewart MWMichael W StewartDepartment of Ophthalmology, Mayo School of Medicine, Jacksonville, FL, USAAbstract: The treatment of center-involving diabetic macular edema (DME) has improved because of the proven efficacy of drugs that inhibit the effects of vascular endothelial growth factor (VEGF). The newest anti-VEGF drug, aflibercept, has recently been approved by the United States Food and Drug Administration for the treatment of center-involving DME and for diabetic retinopathy in eyes with DME. In the pivotal Phase III VISTA and VIVID trials, intravitreal aflibercept 2 mg injections every 4 or 8 weeks (after 5 monthly loading doses) produced superior gains in BCVA compared to laser/sham injections. In the Diabetic Retinopathy Clinical Research Network Protocol T trial, which featured monthly anti-VEGF monotherapy for 6 months, followed by monthly pro re nata anti-VEGF injections with laser rescue therapy from months 6 through 12, aflibercept 2 mg monthly was superior to bevacizumab 1.25 mg and ranibizumab 0.5 mg in eyes with BCVA of 20/50 or worse (aflibercept versus bevacizumab: P<0.001; aflibercept versus ranibizumab: P=0.003), but the three regimens were comparable for eyes with VA of 20/40 or better. Only in the 20/50 or worse subgroup did aflibercept achieve clinical superiority (>5 letter difference) to bevacizumab. Each treatment regimen led to significant macular thinning, with aflibercept being superior to bevacizumab in both visual acuity subgroups (P<0.001 for each), but it was not statistically superior to ranibizumab in either group. In diabetic patients, aflibercept has an excellent safety profile that does not appear to differ from laser/sham or other VEGF inhibitory drugs.Keywords: aflibercept, bevacizumab, diabetic macular edema, ranibizumab, vascular endothelial growth factorhttps://www.dovepress.com/the-clinical-utility-of-aflibercept-for-diabetic-macular-edema-peer-reviewed-article-DMSO
collection DOAJ
language English
format Article
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author Stewart MW
spellingShingle Stewart MW
The clinical utility of aflibercept for diabetic macular edema
Diabetes, Metabolic Syndrome and Obesity : Targets and Therapy
author_facet Stewart MW
author_sort Stewart MW
title The clinical utility of aflibercept for diabetic macular edema
title_short The clinical utility of aflibercept for diabetic macular edema
title_full The clinical utility of aflibercept for diabetic macular edema
title_fullStr The clinical utility of aflibercept for diabetic macular edema
title_full_unstemmed The clinical utility of aflibercept for diabetic macular edema
title_sort clinical utility of aflibercept for diabetic macular edema
publisher Dove Medical Press
series Diabetes, Metabolic Syndrome and Obesity : Targets and Therapy
issn 1178-7007
publishDate 2015-09-01
description Michael W StewartDepartment of Ophthalmology, Mayo School of Medicine, Jacksonville, FL, USAAbstract: The treatment of center-involving diabetic macular edema (DME) has improved because of the proven efficacy of drugs that inhibit the effects of vascular endothelial growth factor (VEGF). The newest anti-VEGF drug, aflibercept, has recently been approved by the United States Food and Drug Administration for the treatment of center-involving DME and for diabetic retinopathy in eyes with DME. In the pivotal Phase III VISTA and VIVID trials, intravitreal aflibercept 2 mg injections every 4 or 8 weeks (after 5 monthly loading doses) produced superior gains in BCVA compared to laser/sham injections. In the Diabetic Retinopathy Clinical Research Network Protocol T trial, which featured monthly anti-VEGF monotherapy for 6 months, followed by monthly pro re nata anti-VEGF injections with laser rescue therapy from months 6 through 12, aflibercept 2 mg monthly was superior to bevacizumab 1.25 mg and ranibizumab 0.5 mg in eyes with BCVA of 20/50 or worse (aflibercept versus bevacizumab: P<0.001; aflibercept versus ranibizumab: P=0.003), but the three regimens were comparable for eyes with VA of 20/40 or better. Only in the 20/50 or worse subgroup did aflibercept achieve clinical superiority (>5 letter difference) to bevacizumab. Each treatment regimen led to significant macular thinning, with aflibercept being superior to bevacizumab in both visual acuity subgroups (P<0.001 for each), but it was not statistically superior to ranibizumab in either group. In diabetic patients, aflibercept has an excellent safety profile that does not appear to differ from laser/sham or other VEGF inhibitory drugs.Keywords: aflibercept, bevacizumab, diabetic macular edema, ranibizumab, vascular endothelial growth factor
url https://www.dovepress.com/the-clinical-utility-of-aflibercept-for-diabetic-macular-edema-peer-reviewed-article-DMSO
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