Two-year outcomes of the treat-and-extend regimen using aflibercept for treating diabetic macular oedema.

Published on Dec 16, 2020in Scientific Reports3.998
· DOI :10.1038/S41598-020-78954-3
Yu Cheol Kim2
Estimated H-index: 2
(KMU: Keimyung University),
Yu Cheol Kim7
Estimated H-index: 7
(KMU: Keimyung University)
+ 6 AuthorsJi Eun Lee19
Estimated H-index: 19
(PNU: Pusan National University)
Sources
Abstract
This study was performed to investigate the efficacy of the treat-and-extend regimen using aflibercept for treating diabetic macular oedema (DME). This prospective, multicentre, interventional, single-arm, 104-week clinical trial included 48 patients with DME visual impairment. The patients' eyes received five consecutive intravitreal injections (2 mg aflibercept) every four weeks with two-week adjustments based on central subfield macular thickness (CSMT) changes. Injections were deferred when CSMT was stable. The number of injections, best-corrected visual acuity (BCVA), CSMT, and diabetic retinopathy severity scale scores were analysed. Compared to baseline, BCVA improved by + 9.1 letters at 52 weeks and was maintained with + 9.4-letter gain at 104 weeks (P < 0.001). Between baseline and 104 weeks, CSMT decreased from 489 to 298 μm (P < 0.001) and eyes with vision ≥ 20/40 increased from 17.4 to 43.5% (P = 0.007). The mean number of injections decreased from 8.5 in year one to 3.9 in year two. The injection interval was extended to ≥ 12 weeks in 56.5% of patients. The treat-and-extend regimen of aflibercept in DME showed 2-year efficacy comparable to that of fixed dosing regimens. The flexible dosing of this regimen reduced the number of injections in year two while maintaining efficacy.
References20
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#2Masahiko Sugimoto (Mie University)H-Index: 14
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1 CitationsSource
#1Hiroki Mieno (Kyoto Prefectural University of Medicine)H-Index: 3
#2Kazuhito Yoneda (Kyoto Prefectural University of Medicine)H-Index: 9
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PURPOSE To investigate the efficacy of aflibercept for the treatment of diabetic macular edema via a treat-and-extend regimen. METHODS This prospective, single-center, open-label, interventional study involved 30 patients with a best-corrected visual acuity (BCVA) ≤0.6 and a central retinal thickness (CRT) ≥300 μm. The enrolled eyes each received a monthly intravitreal aflibercept injection until the CRT decreased below 300 μm, upon which the administration interval was extended for 1 month unti...
2 CitationsSource
#1Beverley Curry (Hobart Corporation)H-Index: 2
#2Paul G. Sanfilippo (University of Melbourne)H-Index: 15
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Introduction Treat-and-extend (TE ‘as needed’) regimens of intravitreal anti-vascular endothelial growth factor (VEGF) treatment have been found to reduce the injection burden on patients and improve the cost effectiveness of the treatment of macular edema. The aim of this study was to assess the effectiveness of a T&E regimen of aflibercept, in a clinical setting, in patients with diabetic macular edema (DME) who were either intravitreal anti-VEGF therapy naive or with minimal exposure to anti-...
8 CitationsSource
#1Kang Yeun Pak (Inje University)H-Index: 3
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INTRODUCTION: The purpose of this study was to report the one-year results of treatment of diabetic macular edema (DME) with aflibercept using a treat-and-extend regimen (TER). METHODS: This was a prospective, multicenter, single-arm study planned for 2 years. The eyes received 5 consecutive intravitreal injections of 2 mg of aflibercept every 4 weeks, and the interval between injections was then adjusted by 2 weeks based on changes in the central subfield macular thickness (CSMT). If the CSMT w...
6 CitationsSource
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Purpose To prospectively evaluate a treat and extend algorithm of ranibizumab with and without navigated laser to monthly dosing for center-involving diabetic macular edema. Design This was a multicenter, randomized, clinical trial. Methods One hundred fifty eyes were randomized into 3 cohorts: monthly (n = 30), treat and extend without laser photocoagulation (TREX; n = 60), and treat and extend with angiography-guided laser photocoagulation (GILA; n = 60). Monthly cohort eyes received ranibizum...
16 CitationsSource
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Purpose To present the rationale, guidelines, and results of ranibizumab treatment for proliferative diabetic retinopathy (PDR) in Diabetic Retinopathy Clinical Research Network ( DRCR.net ) Protocol S. Design Post hoc analyses from a randomized clinical trial. Participants Three hundred five participants (394 study eyes) having PDR without prior panretinal photocoagulation (PRP). Methods Intravitreous ranibizumab (0.5 mg) versus PRP for PDR. Ranbizumab-assigned eyes (n = 191) received monthly i...
33 CitationsSource
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#2András Berta (University of Debrecen)H-Index: 30
Last. Jordi MonésH-Index: 28
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109 CitationsSource
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#2Claudio Azzolini (University of Insubria)H-Index: 24
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PurposeTo reach a consensus, among experts, on the role of aflibercept in diabetic macular edema (DME) through literature review.MethodsTwo round tables, involving 12 Italian experts, were organize...
14 CitationsSource
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#2Charles C. Wykoff (Houston Methodist Hospital)H-Index: 3
Last. David M. Brown (Houston Methodist Hospital)H-Index: 42
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Purpose To compare monthly dosing with a treat and extend algorithm using ranibizumab 0.3 mg with and without angiography-guided macular laser photocoagulation for center-involving diabetic macular edema (DME). Design Multicenter, prospective, randomized clinical trial. Participants A total of 150 eyes from 116 subjects were randomized into 3 cohorts: Monthly (n = 30), TReat and EXtend without macular laser photocoagulation (TREX; n = 60), and treat and extend with angiography-GuIded macular LAs...
38 CitationsSource
#1Jeffrey S. HeierH-Index: 57
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Purpose To compare efficacy and safety of intravitreal aflibercept injection (IAI) with macular laser photocoagulation for diabetic macular edema (DME) over 3 years. Design Two similarly designed phase 3 trials: VISTA DME and VIVID DME . Participants Patients (eyes; n = 872) with central-involved DME. Methods Eyes received IAI 2 mg every 4 weeks (2q4), IAI 2 mg every 8 weeks after 5 monthly doses (2q8), or laser control. From week 24, if rescue treatment criteria were met, IAI patients received ...
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Cited By2
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#1Wei-Hsuan Huang (Memorial Hospital of South Bend)
#2Chi-Chun Lai (Memorial Hospital of South Bend)H-Index: 24
Last. Ling Yeung (Memorial Hospital of South Bend)H-Index: 16
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Purpose: To investigate the association between foveal microvascular integrity and anti-vascular endothelial growth factor (VEGF) treatment response for diabetic macular edema (DME). Methods: This retrospective study enrolled 58 eyes (from 45 patients) with DME. Treatment strategy was three to five monthly anti-VEGF injections followed by a PRN protocol. Treatment with an intravitreal corticosteroid would be considered for persistent DME after five consecutive anti-VEGF injections. Eyes achievin...
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#1Mathias Gallardo (University of Bern)H-Index: 2
#1Mathias Gallardo (University of Bern)H-Index: 1
Last. Raphael Sznitman (University of Bern)H-Index: 20
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Abstract Purpose To assess the potential of machine learning to predict low and high treatment demand in real life in patients with nAMD, RVO and DME treated according to a TER. Design Retrospective cohort study. Participants 377 eyes (340 patients) with nAMD, 333 eyes (285 patients) with RVO or DME, treated with anti-VEGF according to a predefined TER protocol during 2014-2018. Methods Eyes were grouped by disease into low, moderate and high treatment demanders, defined by the average treatment...
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