Dexamethasone Intravitreal Implant for the Treatment of Macular Edema Following Retinal Vein Occlusion: Post Hoc Analysis of Post-Marketing Surveillance Data in the Real-World Setting in Korea

Min Seok Kim,1 Jasmine Choi,2 Hyeong Du Lee,3 Se Joon Woo1 On behalf of the Korea Ozurdex Post-Marketing Surveillance Study Group1Department of Ophthalmology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea; 2Allergan, an AbbVie Company, Irv...

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Autores principales:	Kim MS, Choi J, Lee HD, Woo SJ
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2021
Materias:	retinal vein occlusion dexamethasone intravitreal implant post-marketing real world Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/b5ed8356c26644b6af9e6b85e823e97b
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spelling	oai:doaj.org-article:b5ed8356c26644b6af9e6b85e823e97b2021-12-02T16:18:04ZDexamethasone Intravitreal Implant for the Treatment of Macular Edema Following Retinal Vein Occlusion: Post Hoc Analysis of Post-Marketing Surveillance Data in the Real-World Setting in Korea1177-5483https://doaj.org/article/b5ed8356c26644b6af9e6b85e823e97b2021-08-01T00:00:00Zhttps://www.dovepress.com/dexamethasone-intravitreal-implant-for-the-treatment-of-macular-edema--peer-reviewed-fulltext-article-OPTHhttps://doaj.org/toc/1177-5483Min Seok Kim,1 Jasmine Choi,2 Hyeong Du Lee,3 Se Joon Woo1 On behalf of the Korea Ozurdex Post-Marketing Surveillance Study Group1Department of Ophthalmology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea; 2Allergan, an AbbVie Company, Irvine, CA, USA; 3Allergan, an AbbVie Company, Seoul, KoreaCorrespondence: Se Joon WooDepartment of Ophthalmology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, 173-82 Gumi-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, 13620, Republic of KoreaTel +82-31-787-7377Fax +82-31-787-4057Email sejoon1@snu.ac.krPurpose: To supplement established efficacy and safety data, this analysis evaluated the real-world use of dexamethasone (DEX) intravitreal implant 700 μg for retinal vein occlusion (RVO)-related macular edema in an Asian population and baseline factors potentially associated with DEX implant efficacy.Patients and Methods: A prospective, observational, post-marketing surveillance study was conducted at 38 sites in South Korea in patients consecutively presenting with macular edema following branch or central RVO (BRVO, CRVO), and administered a first DEX implant. Follow-up visits and subsequent DEX or other therapies conformed with local practice. Outcome measures included best-corrected visual acuity (BCVA), change in BCVA from baseline, responder rates, and adverse events. Associations between baseline characteristics and BCVA gains were evaluated. Month-1, -2, -4, and -6 visit analysis windows were established.Results: In all, 700 patients (79.1% BRVO, 20.9% CRVO) received 1.12 DEX implants (mean) and were followed for 101.5 days (standard deviation, 51.7); 90% received a single implant. Among patients with analyzable data, mean BCVA improved from baseline with peak changes in Month 2 of − 0.193 and − 0.212 LogMAR, (P < 0.0001) and remained significant in the BRVO subgroup at the Month 4 and 6 windows (P < 0.0001 and P = 0.0039, respectively). Treatment-naïve patients experienced greater BCVA increases. The proportion of patients with stable/improved BCVA tended to decrease after Month 2 through Month 6 and the decline was greater in the CRVO subgroup. At the Month-2 window, ≥ 1-, 2- and 3-line increases were positively associated with younger age, worse baseline BCVA, and treatment naivety. The most common adverse event was increased intraocular pressure.Conclusion: In the real-world clinical setting in South Korea, DEX implant improved visual acuity and had a favorable safety profile similar to that reported in randomized controlled trials and observational European and North American studies. These data further support the value of DEX implant as a treatment option for RVO.ClinicalTrials.gov Identifier: NCT01976650. Date of registration: November 6, 2013.Keywords: retinal vein occlusion, dexamethasone, intravitreal, implant, post-marketing, real worldKim MSChoi JLee HDWoo SJDove Medical Pressarticleretinal vein occlusiondexamethasoneintravitrealimplantpost-marketingreal worldOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 15, Pp 3623-3636 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	retinal vein occlusion dexamethasone intravitreal implant post-marketing real world Ophthalmology RE1-994
spellingShingle	retinal vein occlusion dexamethasone intravitreal implant post-marketing real world Ophthalmology RE1-994 Kim MS Choi J Lee HD Woo SJ Dexamethasone Intravitreal Implant for the Treatment of Macular Edema Following Retinal Vein Occlusion: Post Hoc Analysis of Post-Marketing Surveillance Data in the Real-World Setting in Korea
description	Min Seok Kim,1 Jasmine Choi,2 Hyeong Du Lee,3 Se Joon Woo1 On behalf of the Korea Ozurdex Post-Marketing Surveillance Study Group1Department of Ophthalmology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea; 2Allergan, an AbbVie Company, Irvine, CA, USA; 3Allergan, an AbbVie Company, Seoul, KoreaCorrespondence: Se Joon WooDepartment of Ophthalmology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, 173-82 Gumi-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, 13620, Republic of KoreaTel +82-31-787-7377Fax +82-31-787-4057Email sejoon1@snu.ac.krPurpose: To supplement established efficacy and safety data, this analysis evaluated the real-world use of dexamethasone (DEX) intravitreal implant 700 μg for retinal vein occlusion (RVO)-related macular edema in an Asian population and baseline factors potentially associated with DEX implant efficacy.Patients and Methods: A prospective, observational, post-marketing surveillance study was conducted at 38 sites in South Korea in patients consecutively presenting with macular edema following branch or central RVO (BRVO, CRVO), and administered a first DEX implant. Follow-up visits and subsequent DEX or other therapies conformed with local practice. Outcome measures included best-corrected visual acuity (BCVA), change in BCVA from baseline, responder rates, and adverse events. Associations between baseline characteristics and BCVA gains were evaluated. Month-1, -2, -4, and -6 visit analysis windows were established.Results: In all, 700 patients (79.1% BRVO, 20.9% CRVO) received 1.12 DEX implants (mean) and were followed for 101.5 days (standard deviation, 51.7); 90% received a single implant. Among patients with analyzable data, mean BCVA improved from baseline with peak changes in Month 2 of − 0.193 and − 0.212 LogMAR, (P < 0.0001) and remained significant in the BRVO subgroup at the Month 4 and 6 windows (P < 0.0001 and P = 0.0039, respectively). Treatment-naïve patients experienced greater BCVA increases. The proportion of patients with stable/improved BCVA tended to decrease after Month 2 through Month 6 and the decline was greater in the CRVO subgroup. At the Month-2 window, ≥ 1-, 2- and 3-line increases were positively associated with younger age, worse baseline BCVA, and treatment naivety. The most common adverse event was increased intraocular pressure.Conclusion: In the real-world clinical setting in South Korea, DEX implant improved visual acuity and had a favorable safety profile similar to that reported in randomized controlled trials and observational European and North American studies. These data further support the value of DEX implant as a treatment option for RVO.ClinicalTrials.gov Identifier: NCT01976650. Date of registration: November 6, 2013.Keywords: retinal vein occlusion, dexamethasone, intravitreal, implant, post-marketing, real world
format	article
author	Kim MS Choi J Lee HD Woo SJ
author_facet	Kim MS Choi J Lee HD Woo SJ
author_sort	Kim MS
title	Dexamethasone Intravitreal Implant for the Treatment of Macular Edema Following Retinal Vein Occlusion: Post Hoc Analysis of Post-Marketing Surveillance Data in the Real-World Setting in Korea
title_short	Dexamethasone Intravitreal Implant for the Treatment of Macular Edema Following Retinal Vein Occlusion: Post Hoc Analysis of Post-Marketing Surveillance Data in the Real-World Setting in Korea
title_full	Dexamethasone Intravitreal Implant for the Treatment of Macular Edema Following Retinal Vein Occlusion: Post Hoc Analysis of Post-Marketing Surveillance Data in the Real-World Setting in Korea
title_fullStr	Dexamethasone Intravitreal Implant for the Treatment of Macular Edema Following Retinal Vein Occlusion: Post Hoc Analysis of Post-Marketing Surveillance Data in the Real-World Setting in Korea
title_full_unstemmed	Dexamethasone Intravitreal Implant for the Treatment of Macular Edema Following Retinal Vein Occlusion: Post Hoc Analysis of Post-Marketing Surveillance Data in the Real-World Setting in Korea
title_sort	dexamethasone intravitreal implant for the treatment of macular edema following retinal vein occlusion: post hoc analysis of post-marketing surveillance data in the real-world setting in korea
publisher	Dove Medical Press
publishDate	2021
url	https://doaj.org/article/b5ed8356c26644b6af9e6b85e823e97b
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Dexamethasone Intravitreal Implant for the Treatment of Macular Edema Following Retinal Vein Occlusion: Post Hoc Analysis of Post-Marketing Surveillance Data in the Real-World Setting in Korea

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