Rapid Structural and Functional Improvements with the 0.19 mg Fluocinolone Acetonide Intravitreal Implant for Patients with DME and Low Visual Acuity: 6-Month Data from the UAE

Ahmed Mohammed Elbarky1,2 1Vitreoretinal consultant, Sheikh Khalifa Medical City, Abu Dhabi, United Arab Emirates; 2Department of Ophthalmology, Benha Faculty of Medicine, Benha University, Benha, EgyptCorrespondence: Ahmed Mohammed Elbarky Email abarky@yahoo.comPurpose: The 0.19 mg fluocinolone ace...

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Autor principal:	Elbarky AM
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2020
Materias:	diabetic macular edema fluocinolone acetonide intravitreal implant clinical evidence. Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/2ece8fb91aa44df6876e3e866ee8e541
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spelling	oai:doaj.org-article:2ece8fb91aa44df6876e3e866ee8e5412021-12-02T15:20:16ZRapid Structural and Functional Improvements with the 0.19 mg Fluocinolone Acetonide Intravitreal Implant for Patients with DME and Low Visual Acuity: 6-Month Data from the UAE1177-5483https://doaj.org/article/2ece8fb91aa44df6876e3e866ee8e5412020-03-01T00:00:00Zhttps://www.dovepress.com/rapid-structural-and-functional-improvements-with-the-019-mg-fluocinol-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Ahmed Mohammed Elbarky1,2 1Vitreoretinal consultant, Sheikh Khalifa Medical City, Abu Dhabi, United Arab Emirates; 2Department of Ophthalmology, Benha Faculty of Medicine, Benha University, Benha, EgyptCorrespondence: Ahmed Mohammed Elbarky Email abarky@yahoo.comPurpose: The 0.19 mg fluocinolone acetonide (FAc) intravitreal implant is approved in the United Arab Emirates (UAE) for treating diabetic macular edema (DME) in patients previously treated with a course of corticosteroids and that did not have a clinically significant rise in intraocular pressure (IOP). This ongoing study is assessing its effectiveness and safety in pseudophakic patients with DME in clinical practice from a single center in the UAE.Methods: A retrospective, ongoing 6-month audit study (NCT03590587), in which 22 eyes from 22 patients were treated with a single FAc intravitreal implant after treatment with a prior course of corticosteroids. Outcomes assessed included mean changes in best-corrected visual acuity (BCVA), central macular thickness (CMT), and IOP. Six-month follow-up data are presented.Results: After FAc implantation, mean BCVA improved rapidly, increasing by 25.4 ± 3.0 letters (mean±SEM) from baseline to Month 6 (p< 0.0001). At 6 months, BCVA had improved by 15 letters or more in 91% of eyes (n=20/22). Mean CMT decreased by 267.0 ± 20.1 μm from baseline to Month 6 (p< 0.0001). Over 85% of eyes (n=19/22) had a CMT less than 300 μm at 6 months. Mean IOP increased by 2.9 ± 0.7 mmHg from baseline to Month 6 (p< 0.001). All eyes except 2 had an IOP of 21 mmHg or lower. At Month 6, five eyes (23%) needed IOP-lowering therapy.Conclusion: Injection of the FAc intravitreal implant rapidly and significantly improved BCVA and CMT within 6 months. These rapid and significant improvements exceed those reported in other real-world studies. Safety signals were consistent with corticosteroid class effects. The FAc implant may be a useful treatment option for patients in the UAE, particularly those with sight threatening DME requiring rapid functional improvements.Keywords: diabetic macular edema, fluocinolone acetonide intravitreal implant, clinical evidenceElbarky AMDove Medical Pressarticlediabetic macular edemafluocinolone acetonide intravitreal implantclinical evidence.OphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 14, Pp 823-830 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	diabetic macular edema fluocinolone acetonide intravitreal implant clinical evidence. Ophthalmology RE1-994
spellingShingle	diabetic macular edema fluocinolone acetonide intravitreal implant clinical evidence. Ophthalmology RE1-994 Elbarky AM Rapid Structural and Functional Improvements with the 0.19 mg Fluocinolone Acetonide Intravitreal Implant for Patients with DME and Low Visual Acuity: 6-Month Data from the UAE
description	Ahmed Mohammed Elbarky1,2 1Vitreoretinal consultant, Sheikh Khalifa Medical City, Abu Dhabi, United Arab Emirates; 2Department of Ophthalmology, Benha Faculty of Medicine, Benha University, Benha, EgyptCorrespondence: Ahmed Mohammed Elbarky Email abarky@yahoo.comPurpose: The 0.19 mg fluocinolone acetonide (FAc) intravitreal implant is approved in the United Arab Emirates (UAE) for treating diabetic macular edema (DME) in patients previously treated with a course of corticosteroids and that did not have a clinically significant rise in intraocular pressure (IOP). This ongoing study is assessing its effectiveness and safety in pseudophakic patients with DME in clinical practice from a single center in the UAE.Methods: A retrospective, ongoing 6-month audit study (NCT03590587), in which 22 eyes from 22 patients were treated with a single FAc intravitreal implant after treatment with a prior course of corticosteroids. Outcomes assessed included mean changes in best-corrected visual acuity (BCVA), central macular thickness (CMT), and IOP. Six-month follow-up data are presented.Results: After FAc implantation, mean BCVA improved rapidly, increasing by 25.4 ± 3.0 letters (mean±SEM) from baseline to Month 6 (p< 0.0001). At 6 months, BCVA had improved by 15 letters or more in 91% of eyes (n=20/22). Mean CMT decreased by 267.0 ± 20.1 μm from baseline to Month 6 (p< 0.0001). Over 85% of eyes (n=19/22) had a CMT less than 300 μm at 6 months. Mean IOP increased by 2.9 ± 0.7 mmHg from baseline to Month 6 (p< 0.001). All eyes except 2 had an IOP of 21 mmHg or lower. At Month 6, five eyes (23%) needed IOP-lowering therapy.Conclusion: Injection of the FAc intravitreal implant rapidly and significantly improved BCVA and CMT within 6 months. These rapid and significant improvements exceed those reported in other real-world studies. Safety signals were consistent with corticosteroid class effects. The FAc implant may be a useful treatment option for patients in the UAE, particularly those with sight threatening DME requiring rapid functional improvements.Keywords: diabetic macular edema, fluocinolone acetonide intravitreal implant, clinical evidence
format	article
author	Elbarky AM
author_facet	Elbarky AM
author_sort	Elbarky AM
title	Rapid Structural and Functional Improvements with the 0.19 mg Fluocinolone Acetonide Intravitreal Implant for Patients with DME and Low Visual Acuity: 6-Month Data from the UAE
title_short	Rapid Structural and Functional Improvements with the 0.19 mg Fluocinolone Acetonide Intravitreal Implant for Patients with DME and Low Visual Acuity: 6-Month Data from the UAE
title_full	Rapid Structural and Functional Improvements with the 0.19 mg Fluocinolone Acetonide Intravitreal Implant for Patients with DME and Low Visual Acuity: 6-Month Data from the UAE
title_fullStr	Rapid Structural and Functional Improvements with the 0.19 mg Fluocinolone Acetonide Intravitreal Implant for Patients with DME and Low Visual Acuity: 6-Month Data from the UAE
title_full_unstemmed	Rapid Structural and Functional Improvements with the 0.19 mg Fluocinolone Acetonide Intravitreal Implant for Patients with DME and Low Visual Acuity: 6-Month Data from the UAE
title_sort	rapid structural and functional improvements with the 0.19 mg fluocinolone acetonide intravitreal implant for patients with dme and low visual acuity: 6-month data from the uae
publisher	Dove Medical Press
publishDate	2020
url	https://doaj.org/article/2ece8fb91aa44df6876e3e866ee8e541
work_keys_str_mv	AT elbarkyam rapidstructuralandfunctionalimprovementswiththe019mgfluocinoloneacetonideintravitrealimplantforpatientswithdmeandlowvisualacuity6monthdatafromtheuae
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Rapid Structural and Functional Improvements with the 0.19 mg Fluocinolone Acetonide Intravitreal Implant for Patients with DME and Low Visual Acuity: 6-Month Data from the UAE

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