An open-label, one-year, noncomparative study to evaluate the safety and tolerability of intravitreal pegaptanib sodium in patients with diabetic macular edema

Sobha Sivaprasad,1 Richard C Browning,2 Carla Starita2 1Consultant Ophthalmologist, King’s College Hospital, Denmark Hill, London, 2Pfizer Ltd, Walton Oaks, Dorking Road, Tadworth, Surrey, UK Background: The purpose of this study was to evaluate the safety and tolerability of pegaptanib...

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Autores principales:	Sivaprasad S, Browning RC, Starita C
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2014
Materias:	Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/a1de79aa784744a59b289c87bbf37da0
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spelling	oai:doaj.org-article:a1de79aa784744a59b289c87bbf37da02021-12-02T06:06:51ZAn open-label, one-year, noncomparative study to evaluate the safety and tolerability of intravitreal pegaptanib sodium in patients with diabetic macular edema1177-5483https://doaj.org/article/a1de79aa784744a59b289c87bbf37da02014-08-01T00:00:00Zhttp://www.dovepress.com/an-open-label-one-year-noncomparative-study-to-evaluate-the-safety-and-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483 Sobha Sivaprasad,1 Richard C Browning,2 Carla Starita2 1Consultant Ophthalmologist, King’s College Hospital, Denmark Hill, London, 2Pfizer Ltd, Walton Oaks, Dorking Road, Tadworth, Surrey, UK Background: The purpose of this study was to evaluate the safety and tolerability of pegaptanib in patients with diabetic macular edema. Methods: An open-label, multicenter, noncomparative, one-year study of approximately 500 patients was planned. Recruitment was terminated after enrollment of 46 patients. Enrolled patients were fully informed and reconsented; 12 patients elected to complete the study. Patients received intravitreal injections of pegaptanib 0.3 mg once every 6 weeks or less frequently, as determined by the investigator. Clinical benefit was evaluated after the patient received two or more injections. Ocular and nonocular adverse events were closely monitored throughout the study. Results: Compared with baseline, mean best-corrected visual acuity increased by week 6. Ten patients reported ocular-related adverse events, none of which were severe, and eight patients reported nonocular adverse events, two of which were severe but unrelated to study treatment. Three serious adverse events, unrelated to study treatment, were reported.Conclusion: In this limited set of patients with diabetic macular edema, pegaptanib appeared to be well tolerated with evidence of efficacy. Keywords: pegaptanib, diabetic macular edema, safety, tolerabilitySivaprasad SBrowning RCStarita CDove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2014, Iss default, Pp 1565-1571 (2014)
institution	DOAJ
collection	DOAJ
language	EN
topic	Ophthalmology RE1-994
spellingShingle	Ophthalmology RE1-994 Sivaprasad S Browning RC Starita C An open-label, one-year, noncomparative study to evaluate the safety and tolerability of intravitreal pegaptanib sodium in patients with diabetic macular edema
description	Sobha Sivaprasad,1 Richard C Browning,2 Carla Starita2 1Consultant Ophthalmologist, King’s College Hospital, Denmark Hill, London, 2Pfizer Ltd, Walton Oaks, Dorking Road, Tadworth, Surrey, UK Background: The purpose of this study was to evaluate the safety and tolerability of pegaptanib in patients with diabetic macular edema. Methods: An open-label, multicenter, noncomparative, one-year study of approximately 500 patients was planned. Recruitment was terminated after enrollment of 46 patients. Enrolled patients were fully informed and reconsented; 12 patients elected to complete the study. Patients received intravitreal injections of pegaptanib 0.3 mg once every 6 weeks or less frequently, as determined by the investigator. Clinical benefit was evaluated after the patient received two or more injections. Ocular and nonocular adverse events were closely monitored throughout the study. Results: Compared with baseline, mean best-corrected visual acuity increased by week 6. Ten patients reported ocular-related adverse events, none of which were severe, and eight patients reported nonocular adverse events, two of which were severe but unrelated to study treatment. Three serious adverse events, unrelated to study treatment, were reported.Conclusion: In this limited set of patients with diabetic macular edema, pegaptanib appeared to be well tolerated with evidence of efficacy. Keywords: pegaptanib, diabetic macular edema, safety, tolerability
format	article
author	Sivaprasad S Browning RC Starita C
author_facet	Sivaprasad S Browning RC Starita C
author_sort	Sivaprasad S
title	An open-label, one-year, noncomparative study to evaluate the safety and tolerability of intravitreal pegaptanib sodium in patients with diabetic macular edema
title_short	An open-label, one-year, noncomparative study to evaluate the safety and tolerability of intravitreal pegaptanib sodium in patients with diabetic macular edema
title_full	An open-label, one-year, noncomparative study to evaluate the safety and tolerability of intravitreal pegaptanib sodium in patients with diabetic macular edema
title_fullStr	An open-label, one-year, noncomparative study to evaluate the safety and tolerability of intravitreal pegaptanib sodium in patients with diabetic macular edema
title_full_unstemmed	An open-label, one-year, noncomparative study to evaluate the safety and tolerability of intravitreal pegaptanib sodium in patients with diabetic macular edema
title_sort	open-label, one-year, noncomparative study to evaluate the safety and tolerability of intravitreal pegaptanib sodium in patients with diabetic macular edema
publisher	Dove Medical Press
publishDate	2014
url	https://doaj.org/article/a1de79aa784744a59b289c87bbf37da0
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An open-label, one-year, noncomparative study to evaluate the safety and tolerability of intravitreal pegaptanib sodium in patients with diabetic macular edema

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