Outcomes of a 2-year treat-and-extend regimen with aflibercept for diabetic macular edema

Abstract This prospective, open-label, single-arm, non-randomized clinical trial, assessed the efficacy of a 2-year treat-and-extend (T&E) regimen involving intravitreal aflibercept injection (IAI), with the longest treatment interval set to 16 weeks, and adjunct focal/grid laser in diabetic mac...

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Autores principales: Takao Hirano, Yuichi Toriyama, Yoshihiro Takamura, Masahiko Sugimoto, Taiji Nagaoka, Yoshimi Sugiura, Fumiki Okamoto, Michiyuki Saito, Kousuke Noda, Shigeo Yoshida, Akihiro Ishibazawa, Osamu Sawada, Toshinori Murata
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Publicado: Nature Portfolio 2021
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spelling oai:doaj.org-article:f5ae93ccb074428ea8a2b9a23ae711812021-12-02T13:33:51ZOutcomes of a 2-year treat-and-extend regimen with aflibercept for diabetic macular edema10.1038/s41598-021-83811-y2045-2322https://doaj.org/article/f5ae93ccb074428ea8a2b9a23ae711812021-02-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-83811-yhttps://doaj.org/toc/2045-2322Abstract This prospective, open-label, single-arm, non-randomized clinical trial, assessed the efficacy of a 2-year treat-and-extend (T&E) regimen involving intravitreal aflibercept injection (IAI), with the longest treatment interval set to 16 weeks, and adjunct focal/grid laser in diabetic macula edema (DME) patients. We examined 40 eyes (40 adults) with fovea-involving DME from 8 Japanese centers between April 2015 and February 2017. Participants received IAI with an induction period featuring monthly injections and a subsequent T&E period featuring 8–16-week injection interval, adjusted based on optical coherence tomography findings. The primary endpoints were mean changes in the best-corrected visual acuity (BCVA) and central subfield macular thickness (CST) from baseline. Thirty patients (75%) completed the 2-year follow-up. The mean BCVA and CST changed from 60.5 ± 15.6 letters and 499.2 ± 105.6 µm at baseline to 66.6 ± 17.1 letters (P = 0.217) and 315.2 ± 79.0 µm (P < 0.001), respectively, after 2 years. The treatment interval was extended to 12 and 16 weeks in 6.7% and 66.7% of patients, respectively, at the end of 2 years. The T&E aflibercept regimen with the longest treatment interval set to 16 weeks, with adjunct focal/grid laser may be a rational 2-year treatment strategy for DME.Takao HiranoYuichi ToriyamaYoshihiro TakamuraMasahiko SugimotoTaiji NagaokaYoshimi SugiuraFumiki OkamotoMichiyuki SaitoKousuke NodaShigeo YoshidaAkihiro IshibazawaOsamu SawadaToshinori MurataNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-8 (2021)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle Medicine
R
Science
Q
Takao Hirano
Yuichi Toriyama
Yoshihiro Takamura
Masahiko Sugimoto
Taiji Nagaoka
Yoshimi Sugiura
Fumiki Okamoto
Michiyuki Saito
Kousuke Noda
Shigeo Yoshida
Akihiro Ishibazawa
Osamu Sawada
Toshinori Murata
Outcomes of a 2-year treat-and-extend regimen with aflibercept for diabetic macular edema
description Abstract This prospective, open-label, single-arm, non-randomized clinical trial, assessed the efficacy of a 2-year treat-and-extend (T&E) regimen involving intravitreal aflibercept injection (IAI), with the longest treatment interval set to 16 weeks, and adjunct focal/grid laser in diabetic macula edema (DME) patients. We examined 40 eyes (40 adults) with fovea-involving DME from 8 Japanese centers between April 2015 and February 2017. Participants received IAI with an induction period featuring monthly injections and a subsequent T&E period featuring 8–16-week injection interval, adjusted based on optical coherence tomography findings. The primary endpoints were mean changes in the best-corrected visual acuity (BCVA) and central subfield macular thickness (CST) from baseline. Thirty patients (75%) completed the 2-year follow-up. The mean BCVA and CST changed from 60.5 ± 15.6 letters and 499.2 ± 105.6 µm at baseline to 66.6 ± 17.1 letters (P = 0.217) and 315.2 ± 79.0 µm (P < 0.001), respectively, after 2 years. The treatment interval was extended to 12 and 16 weeks in 6.7% and 66.7% of patients, respectively, at the end of 2 years. The T&E aflibercept regimen with the longest treatment interval set to 16 weeks, with adjunct focal/grid laser may be a rational 2-year treatment strategy for DME.
format article
author Takao Hirano
Yuichi Toriyama
Yoshihiro Takamura
Masahiko Sugimoto
Taiji Nagaoka
Yoshimi Sugiura
Fumiki Okamoto
Michiyuki Saito
Kousuke Noda
Shigeo Yoshida
Akihiro Ishibazawa
Osamu Sawada
Toshinori Murata
author_facet Takao Hirano
Yuichi Toriyama
Yoshihiro Takamura
Masahiko Sugimoto
Taiji Nagaoka
Yoshimi Sugiura
Fumiki Okamoto
Michiyuki Saito
Kousuke Noda
Shigeo Yoshida
Akihiro Ishibazawa
Osamu Sawada
Toshinori Murata
author_sort Takao Hirano
title Outcomes of a 2-year treat-and-extend regimen with aflibercept for diabetic macular edema
title_short Outcomes of a 2-year treat-and-extend regimen with aflibercept for diabetic macular edema
title_full Outcomes of a 2-year treat-and-extend regimen with aflibercept for diabetic macular edema
title_fullStr Outcomes of a 2-year treat-and-extend regimen with aflibercept for diabetic macular edema
title_full_unstemmed Outcomes of a 2-year treat-and-extend regimen with aflibercept for diabetic macular edema
title_sort outcomes of a 2-year treat-and-extend regimen with aflibercept for diabetic macular edema
publisher Nature Portfolio
publishDate 2021
url https://doaj.org/article/f5ae93ccb074428ea8a2b9a23ae71181
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