Intravitreal pegaptanib for the treatment of ischemic diabetic macular edema

Christine A Kiire, Rupal Morjaria, Anna Rudenko, Alexina Fantato, Lewis Smith, Amy Smith, Victor Chong Oxford Eye Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, UK Purpose: Pegaptanib has been shown to be effective in treating diabetic macular edema (DME). In the original Phas...

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Autores principales:	Kiire CA, Morjaria R, Rudenko A, Fantato A, Smith L, Smith A, Chong V
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2015
Materias:	macular ischaemia vascular endothelial growth factor inhibitor pegaptanib diabetic macular edema foveal avascular zone Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/93de14aae2b74953924fca4c7bc3de04
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spelling	oai:doaj.org-article:93de14aae2b74953924fca4c7bc3de042021-12-02T09:47:10ZIntravitreal pegaptanib for the treatment of ischemic diabetic macular edema1177-5483https://doaj.org/article/93de14aae2b74953924fca4c7bc3de042015-12-01T00:00:00Zhttps://www.dovepress.com/intravitreal-pegaptanib-for-the-treatment-of-ischemic-diabetic-macular-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Christine A Kiire, Rupal Morjaria, Anna Rudenko, Alexina Fantato, Lewis Smith, Amy Smith, Victor Chong Oxford Eye Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, UK Purpose: Pegaptanib has been shown to be effective in treating diabetic macular edema (DME). In the original Phase II/III trial, however, patients with macular ischemia were excluded. In this study, we treated patients with ischemic DME. Methods: Macular ischemia was defined as a 30% increase in the area of the foveal avascular zone (FAZ) at 45 seconds on fundus fluorescein angiography. In addition, the participants had diffuse foveal-involving DME with a central subfield thickness (CST) of >300 µm on spectral-domain optical coherence tomography. Five intravitreal pegaptanib injections were given 6 weeks apart. The final study visit was 6 weeks after the fifth injection. The primary outcome was change in the size of FAZ. Secondary outcomes were change in best-corrected visual acuity (BCVA) and the change in CST. Results: Thirty participants were enrolled. Three were unable to complete the full course of treatment. Their outcomes were carried forward for the first part of this analysis. There was no statistically significant change in the mean size of the FAZ from baseline to the final visit. Subclassifying participants as those with minimal/moderate ischemia (16 participants, FAZ area <1,000 pixels) and those with more severe ischemia (14 participants, FAZ area >1,000 pixels) also showed no statistically significant change in the mean area of the FAZ. On average, BCVA increased and CST decreased from baseline to the final visit, but these changes were not statistically significant. Using per protocol analysis on those participants who completed the full course of treatment, the mean BCVA increased from 49.2 to 53.9 letters (P=0.046). Conclusion: In this study, intravitreal injection of pegaptanib did not significantly alter the size of the FAZ in participants with varying degrees of ischemic DME. There was, however, a significant improvement in mean BCVA in those who completed the treatment course. Keywords: macular ischemia, anti-VEGF, pegaptanib, diabetic macular edemaKiire CAMorjaria RRudenko AFantato ASmith LSmith AChong VDove Medical Pressarticlemacular ischaemiavascular endothelial growth factor inhibitorpegaptanibdiabetic macular edemafoveal avascular zoneOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2015, Iss Issue 1, Pp 2305-2311 (2015)
institution	DOAJ
collection	DOAJ
language	EN
topic	macular ischaemia vascular endothelial growth factor inhibitor pegaptanib diabetic macular edema foveal avascular zone Ophthalmology RE1-994
spellingShingle	macular ischaemia vascular endothelial growth factor inhibitor pegaptanib diabetic macular edema foveal avascular zone Ophthalmology RE1-994 Kiire CA Morjaria R Rudenko A Fantato A Smith L Smith A Chong V Intravitreal pegaptanib for the treatment of ischemic diabetic macular edema
description	Christine A Kiire, Rupal Morjaria, Anna Rudenko, Alexina Fantato, Lewis Smith, Amy Smith, Victor Chong Oxford Eye Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, UK Purpose: Pegaptanib has been shown to be effective in treating diabetic macular edema (DME). In the original Phase II/III trial, however, patients with macular ischemia were excluded. In this study, we treated patients with ischemic DME. Methods: Macular ischemia was defined as a 30% increase in the area of the foveal avascular zone (FAZ) at 45 seconds on fundus fluorescein angiography. In addition, the participants had diffuse foveal-involving DME with a central subfield thickness (CST) of >300 µm on spectral-domain optical coherence tomography. Five intravitreal pegaptanib injections were given 6 weeks apart. The final study visit was 6 weeks after the fifth injection. The primary outcome was change in the size of FAZ. Secondary outcomes were change in best-corrected visual acuity (BCVA) and the change in CST. Results: Thirty participants were enrolled. Three were unable to complete the full course of treatment. Their outcomes were carried forward for the first part of this analysis. There was no statistically significant change in the mean size of the FAZ from baseline to the final visit. Subclassifying participants as those with minimal/moderate ischemia (16 participants, FAZ area <1,000 pixels) and those with more severe ischemia (14 participants, FAZ area >1,000 pixels) also showed no statistically significant change in the mean area of the FAZ. On average, BCVA increased and CST decreased from baseline to the final visit, but these changes were not statistically significant. Using per protocol analysis on those participants who completed the full course of treatment, the mean BCVA increased from 49.2 to 53.9 letters (P=0.046). Conclusion: In this study, intravitreal injection of pegaptanib did not significantly alter the size of the FAZ in participants with varying degrees of ischemic DME. There was, however, a significant improvement in mean BCVA in those who completed the treatment course. Keywords: macular ischemia, anti-VEGF, pegaptanib, diabetic macular edema
format	article
author	Kiire CA Morjaria R Rudenko A Fantato A Smith L Smith A Chong V
author_facet	Kiire CA Morjaria R Rudenko A Fantato A Smith L Smith A Chong V
author_sort	Kiire CA
title	Intravitreal pegaptanib for the treatment of ischemic diabetic macular edema
title_short	Intravitreal pegaptanib for the treatment of ischemic diabetic macular edema
title_full	Intravitreal pegaptanib for the treatment of ischemic diabetic macular edema
title_fullStr	Intravitreal pegaptanib for the treatment of ischemic diabetic macular edema
title_full_unstemmed	Intravitreal pegaptanib for the treatment of ischemic diabetic macular edema
title_sort	intravitreal pegaptanib for the treatment of ischemic diabetic macular edema
publisher	Dove Medical Press
publishDate	2015
url	https://doaj.org/article/93de14aae2b74953924fca4c7bc3de04
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Intravitreal pegaptanib for the treatment of ischemic diabetic macular edema

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