Aflibercept for clinically significant diabetic macular edema: 12-month results in daily clinical practice

Rafael Campos Polo, Consuelo Rubio Sánchez, Diego Manuel García Guisado, María José Díaz Luque Unit of Retina, Department of Ophthalmology, Hospital Virgen del Puerto, Plasencia, Cáceres, Spain Purpose: To assess the effectiveness a...

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Autores principales:	Campos Polo R, Rubio Sánchez C, Garcia Guisado DM, Díaz Luque MJ
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2018
Materias:	Aflibercept · Central macular thickness · Diabetic macular edema · Routine clinical practce · Visual acuity Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/6e34b3584c21494d9fee47e4d8372bf9
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spelling	oai:doaj.org-article:6e34b3584c21494d9fee47e4d8372bf92021-12-02T06:30:26ZAflibercept for clinically significant diabetic macular edema: 12-month results in daily clinical practice1177-5483https://doaj.org/article/6e34b3584c21494d9fee47e4d8372bf92018-01-01T00:00:00Zhttps://www.dovepress.com/aflibercept-for-clinically-significant-diabetic-macular-edema-12-month-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Rafael Campos Polo, Consuelo Rubio Sánchez, Diego Manuel García Guisado, María José Díaz Luque Unit of Retina, Department of Ophthalmology, Hospital Virgen del Puerto, Plasencia, Cáceres, Spain Purpose: To assess the effectiveness and safety of intravitreal aflibercept in clinically significant diabetic macular edema (DME) in daily clinical practice. Methods: Prospective, open-label, single-center study. Anti-vascular endothelial growth factor naïve patients with clinically significant DME received intravitreal injections of aflibercept 2 mg, five monthly doses followed by a fixed schedule every 2 months for 12 months. The mean change in best-corrected visual acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] letters) was the primary outcome. Results: The mean BCVA improved significantly as compared with baseline at 12 months of treatment (47.3 [14.2] vs 62.2 [13.9] ETDRS letters, P<0.001). Significant improvement in BCVA was already observed at visit 2 after the loading doses of aflibercept. At 12 months, gains in ETDRS letters were documented in all eyes (100%), with gains ≥10 letters in 89.6%, ≥15 letters in 65.5%, and ≥20 letters in 6.9% (n=2). A significant reduction in central macular thickness from a mean of 460.5 (11.8) µm at baseline to 229.0 (43.8) µm at 12 months (P<0.001) was observed. Significant reductions of central macular thickness were already observed after the loading doses and continued lowering throughout the study period. No adverse events occurred. Conclusion: Aflibercept as a first-line therapy was effective and well tolerated for treating clinically significant DME in naïve patients in daily practice. Successful results in terms of improvement of visual and reduction in central macular thickness contribute to provide evidence for the positioning of aflibercept as a first-line indication of newly diagnosed clinically significant DME. Keywords: aflibercept, central macular thickness, diabetic macular edema, routine clinical practice, visual acuityCampos Polo RRubio Sánchez CGarcia Guisado DMDíaz Luque MJDove Medical PressarticleAflibercept · Central macular thickness · Diabetic macular edema · Routine clinical practce · Visual acuityOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 12, Pp 99-104 (2018)
institution	DOAJ
collection	DOAJ
language	EN
topic	Aflibercept · Central macular thickness · Diabetic macular edema · Routine clinical practce · Visual acuity Ophthalmology RE1-994
spellingShingle	Aflibercept · Central macular thickness · Diabetic macular edema · Routine clinical practce · Visual acuity Ophthalmology RE1-994 Campos Polo R Rubio Sánchez C Garcia Guisado DM Díaz Luque MJ Aflibercept for clinically significant diabetic macular edema: 12-month results in daily clinical practice
description	Rafael Campos Polo, Consuelo Rubio Sánchez, Diego Manuel García Guisado, María José Díaz Luque Unit of Retina, Department of Ophthalmology, Hospital Virgen del Puerto, Plasencia, Cáceres, Spain Purpose: To assess the effectiveness and safety of intravitreal aflibercept in clinically significant diabetic macular edema (DME) in daily clinical practice. Methods: Prospective, open-label, single-center study. Anti-vascular endothelial growth factor naïve patients with clinically significant DME received intravitreal injections of aflibercept 2 mg, five monthly doses followed by a fixed schedule every 2 months for 12 months. The mean change in best-corrected visual acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] letters) was the primary outcome. Results: The mean BCVA improved significantly as compared with baseline at 12 months of treatment (47.3 [14.2] vs 62.2 [13.9] ETDRS letters, P<0.001). Significant improvement in BCVA was already observed at visit 2 after the loading doses of aflibercept. At 12 months, gains in ETDRS letters were documented in all eyes (100%), with gains ≥10 letters in 89.6%, ≥15 letters in 65.5%, and ≥20 letters in 6.9% (n=2). A significant reduction in central macular thickness from a mean of 460.5 (11.8) µm at baseline to 229.0 (43.8) µm at 12 months (P<0.001) was observed. Significant reductions of central macular thickness were already observed after the loading doses and continued lowering throughout the study period. No adverse events occurred. Conclusion: Aflibercept as a first-line therapy was effective and well tolerated for treating clinically significant DME in naïve patients in daily practice. Successful results in terms of improvement of visual and reduction in central macular thickness contribute to provide evidence for the positioning of aflibercept as a first-line indication of newly diagnosed clinically significant DME. Keywords: aflibercept, central macular thickness, diabetic macular edema, routine clinical practice, visual acuity
format	article
author	Campos Polo R Rubio Sánchez C Garcia Guisado DM Díaz Luque MJ
author_facet	Campos Polo R Rubio Sánchez C Garcia Guisado DM Díaz Luque MJ
author_sort	Campos Polo R
title	Aflibercept for clinically significant diabetic macular edema: 12-month results in daily clinical practice
title_short	Aflibercept for clinically significant diabetic macular edema: 12-month results in daily clinical practice
title_full	Aflibercept for clinically significant diabetic macular edema: 12-month results in daily clinical practice
title_fullStr	Aflibercept for clinically significant diabetic macular edema: 12-month results in daily clinical practice
title_full_unstemmed	Aflibercept for clinically significant diabetic macular edema: 12-month results in daily clinical practice
title_sort	aflibercept for clinically significant diabetic macular edema: 12-month results in daily clinical practice
publisher	Dove Medical Press
publishDate	2018
url	https://doaj.org/article/6e34b3584c21494d9fee47e4d8372bf9
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Aflibercept for clinically significant diabetic macular edema: 12-month results in daily clinical practice

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