Real-World Outcomes of Intravitreal Aflibercept for Neovascular Age-Related Macular Degeneration: A Large-Scale Postmarketing Surveillance in Korea

Gahyung Ryu,1,2 Donghyoun Noh,1,2 Guihyun Moon,3 Min Sagong1,2 1Department of Ophthalmology, Yeungnam University College of Medicine, Daegu, Republic of Korea; 2Yeungnam Eye Center, Yeungnam University Hospital, Daegu, Republic of Korea; 3Bayer Korea Ltd, Seoul, Republic of KoreaCorrespondence: Min...

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Autores principales:	Ryu G, Noh D, Moon G, Sagong M
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2021
Materias:	aflibercept asian neovascular age-related macular degeneration polypoidal choroidal vasculopathy postmarketing surveillance real-world Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/c20c870cc74f4cc9bbe1da53087d5040
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spelling	oai:doaj.org-article:c20c870cc74f4cc9bbe1da53087d50402021-12-02T16:18:04ZReal-World Outcomes of Intravitreal Aflibercept for Neovascular Age-Related Macular Degeneration: A Large-Scale Postmarketing Surveillance in Korea1177-5483https://doaj.org/article/c20c870cc74f4cc9bbe1da53087d50402021-08-01T00:00:00Zhttps://www.dovepress.com/real-world-outcomes-of-intravitreal-aflibercept-for-neovascular-age-re-peer-reviewed-fulltext-article-OPTHhttps://doaj.org/toc/1177-5483Gahyung Ryu,1,2 Donghyoun Noh,1,2 Guihyun Moon,3 Min Sagong1,2 1Department of Ophthalmology, Yeungnam University College of Medicine, Daegu, Republic of Korea; 2Yeungnam Eye Center, Yeungnam University Hospital, Daegu, Republic of Korea; 3Bayer Korea Ltd, Seoul, Republic of KoreaCorrespondence: Min SagongDepartment of Ophthalmology, Yeungnam University College of Medicine, 170 Hyunchungro, Nam-gu, Daegu, 42415, Republic of KoreaTel +82-53-620-3443Fax +82-53-626-5936Email msagong@yu.ac.krPurpose: To investigate the efficacy and safety of intravitreal aflibercept (IVT-AFL) in Asian patients with neovascular age-related macular degeneration (nAMD) in a real-world clinical setting.Patients and Methods: In this analysis of a prospective, regulatory, postmarketing surveillance study for IVT-AFL, 3115 patients with nAMD were included and followed for 8 months. The mean changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were analyzed using last observation carried forward method. A post hoc subgroup analysis and a multivariate logistic regression analysis were also performed to assess factors related to treatment outcomes.Results: Mean BCVA improved from 0.62 to 0.51 logarithm of minimum angle resolution and mean CRT decreased from 383.3 to 289.7 μm, with a mean of 3.4 injections during the 8-month follow-up. In the subgroup analysis, patients who had received 3 initial monthly doses had significantly better anatomical improvements than those treated as needed. Patients with confirmed polypoidal choroidal vasculopathy (PCV) had significantly better anatomical improvements and better visual recovery than those with other types of nAMD. The multivariate regression analysis demonstrated that age, injection number, PCV, and baseline BCVA were significantly associated with higher odds of gaining 3 lines at 8 months, and sex, injection number, PCV, and baseline CRT were associated with CRT ≤ 250 μm at 8 months. No new safety findings were identified.Conclusion: IVT-AFL was effective and well tolerated in a real-world setting with a large number of Asian patients with nAMD. Number of injections and PCV were important determinants for improved treatment outcomes.Keywords: aflibercept, Asian, neovascular age-related macular degeneration, polypoidal choroidal vasculopathy, postmarketing surveillance, real-worldRyu GNoh DMoon GSagong MDove Medical Pressarticleafliberceptasianneovascular age-related macular degenerationpolypoidal choroidal vasculopathypostmarketing surveillancereal-worldOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 15, Pp 3601-3611 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	aflibercept asian neovascular age-related macular degeneration polypoidal choroidal vasculopathy postmarketing surveillance real-world Ophthalmology RE1-994
spellingShingle	aflibercept asian neovascular age-related macular degeneration polypoidal choroidal vasculopathy postmarketing surveillance real-world Ophthalmology RE1-994 Ryu G Noh D Moon G Sagong M Real-World Outcomes of Intravitreal Aflibercept for Neovascular Age-Related Macular Degeneration: A Large-Scale Postmarketing Surveillance in Korea
description	Gahyung Ryu,1,2 Donghyoun Noh,1,2 Guihyun Moon,3 Min Sagong1,2 1Department of Ophthalmology, Yeungnam University College of Medicine, Daegu, Republic of Korea; 2Yeungnam Eye Center, Yeungnam University Hospital, Daegu, Republic of Korea; 3Bayer Korea Ltd, Seoul, Republic of KoreaCorrespondence: Min SagongDepartment of Ophthalmology, Yeungnam University College of Medicine, 170 Hyunchungro, Nam-gu, Daegu, 42415, Republic of KoreaTel +82-53-620-3443Fax +82-53-626-5936Email msagong@yu.ac.krPurpose: To investigate the efficacy and safety of intravitreal aflibercept (IVT-AFL) in Asian patients with neovascular age-related macular degeneration (nAMD) in a real-world clinical setting.Patients and Methods: In this analysis of a prospective, regulatory, postmarketing surveillance study for IVT-AFL, 3115 patients with nAMD were included and followed for 8 months. The mean changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were analyzed using last observation carried forward method. A post hoc subgroup analysis and a multivariate logistic regression analysis were also performed to assess factors related to treatment outcomes.Results: Mean BCVA improved from 0.62 to 0.51 logarithm of minimum angle resolution and mean CRT decreased from 383.3 to 289.7 μm, with a mean of 3.4 injections during the 8-month follow-up. In the subgroup analysis, patients who had received 3 initial monthly doses had significantly better anatomical improvements than those treated as needed. Patients with confirmed polypoidal choroidal vasculopathy (PCV) had significantly better anatomical improvements and better visual recovery than those with other types of nAMD. The multivariate regression analysis demonstrated that age, injection number, PCV, and baseline BCVA were significantly associated with higher odds of gaining 3 lines at 8 months, and sex, injection number, PCV, and baseline CRT were associated with CRT ≤ 250 μm at 8 months. No new safety findings were identified.Conclusion: IVT-AFL was effective and well tolerated in a real-world setting with a large number of Asian patients with nAMD. Number of injections and PCV were important determinants for improved treatment outcomes.Keywords: aflibercept, Asian, neovascular age-related macular degeneration, polypoidal choroidal vasculopathy, postmarketing surveillance, real-world
format	article
author	Ryu G Noh D Moon G Sagong M
author_facet	Ryu G Noh D Moon G Sagong M
author_sort	Ryu G
title	Real-World Outcomes of Intravitreal Aflibercept for Neovascular Age-Related Macular Degeneration: A Large-Scale Postmarketing Surveillance in Korea
title_short	Real-World Outcomes of Intravitreal Aflibercept for Neovascular Age-Related Macular Degeneration: A Large-Scale Postmarketing Surveillance in Korea
title_full	Real-World Outcomes of Intravitreal Aflibercept for Neovascular Age-Related Macular Degeneration: A Large-Scale Postmarketing Surveillance in Korea
title_fullStr	Real-World Outcomes of Intravitreal Aflibercept for Neovascular Age-Related Macular Degeneration: A Large-Scale Postmarketing Surveillance in Korea
title_full_unstemmed	Real-World Outcomes of Intravitreal Aflibercept for Neovascular Age-Related Macular Degeneration: A Large-Scale Postmarketing Surveillance in Korea
title_sort	real-world outcomes of intravitreal aflibercept for neovascular age-related macular degeneration: a large-scale postmarketing surveillance in korea
publisher	Dove Medical Press
publishDate	2021
url	https://doaj.org/article/c20c870cc74f4cc9bbe1da53087d5040
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Real-World Outcomes of Intravitreal Aflibercept for Neovascular Age-Related Macular Degeneration: A Large-Scale Postmarketing Surveillance in Korea

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