One-Year Results of Treatment of Diabetic Macular Edema with Aflibercept Using the Treat-and-Extend Dosing Regimen: the VIBIM Study.

Published on Jan 8, 2020in Ophthalmologica1.926
· DOI :10.1159/000504753
Kang Yeun Pak7
Estimated H-index: 7
(Inje University),
Jae Pil Shin17
Estimated H-index: 17
(KNU: Kyungpook National University)
+ 6 AuthorsJi Eun Lee19
Estimated H-index: 19
(PNU: Pusan National University)
Sources
Abstract
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 was worse, stable, or better, the interval was shortened, extended, or maintained, respectively. The primary outcome measure was the change in best-corrected visual acuity (BCVA) from baseline to 104 weeks, and the secondary outcome was the change in BCVA from baseline to 52 weeks. RESULTS: Of the 48 patients enrolled, 46 completed a 1-year visit. BCVA improved significantly by 9.1 letters (95% confidence interval: 5.3-13.0 letters) from 56.2 letters at baseline (p /=15 letters was 28.3%. The mean number of injections was 8.5 times for 52 weeks. Worsening of macular edema did not occur in 76.1% of eyes during the extension period, and the interval between injections was extended to 12 weeks in 73.9% of eyes at 52 weeks. CONCLUSIONS: The TER showed 1-year efficacy comparable to that of the fixed dosing regimen of pivotal trials, and its flexible dosing would prevent overtreatment.
📖 Papers frequently viewed together
20212.46Eye
12 Authors (Liran Tiosano, ..., Itay Chowers)
1 Citations
13 Citations
References0
Newest
Cited By6
Newest
#1Patricia Take (GAU: University of Göttingen)
#2Carolin Alisa Dittmann (GAU: University of Göttingen)
Last. Sebastian Bemme (GAU: University of Göttingen)H-Index: 5
view all 8 authors...
Die regelmasige Therapie mittels intravitrealer operativer Medikamentenapplikation (IVOM) und die damit verbundenen Kontrolluntersuchungen stellen fur viele Patienten eine grose Herausforderung dar, die bis zum Behandlungsabbruch fuhren kann. Das modifizierte blockweise Treat-and-Extend(TAE)-Schema verfolgt das Ziel, mit moglichst wenigen Kontrollvisiten stabile Netzhaut- und Visusbefunde zu erreichen und dadurch die Belastung der Patienten zu minimieren. Diese monozentrische retrospektive Studi...
Source
Source
#1Takao Hirano (Shinshu University)H-Index: 11
#2Yuichi Toriyama (Shinshu University)H-Index: 15
Last. Toshinori Murata (Shinshu University)H-Index: 20
view all 13 authors...
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...
1 CitationsSource
#1Takao Hirano (Shinshu University)H-Index: 11
#2Yuichi Toriyama (Shinshu University)H-Index: 15
Last. Toshinori Murata (Shinshu University)H-Index: 20
view all 13 authors...
PURPOSE To investigate the efficacy and safety of a treat-and-extend (T&E) regimen using aflibercept (Eylea) for diabetic macular edema (DME). STUDY DESIGN Prospective, open-label, multicenter, single-arm, nonblinded clinical study. METHODS Forty eyes of 40 patients with DME received a T&E regimen of intravitreal aflibercept injection (IAI) with the longest treatment interval set to 16 weeks and adjunct focal/grid laser for 1 year. An intent-to-treat analysis was performed using the same last-ob...
Source
#1Daniele VerittiH-Index: 14
#2Valentina SaraoH-Index: 14
Last. Paolo LanzettaH-Index: 32
view all 4 authors...
Purpose This meta-analysis aims to summarize 12-month best-corrected visual acuity (BCVA) outcomes in response to anti-vascular endothelial growth factor (VEGF) therapy and dexamethasone implant for the treatment of diabetic macular edema (DME) and to identify factors affecting treatment response using evidence generated from meta-regression. Methods A systematic review of electronic databases was conducted to identify randomized controlled trials (RCTs) and real-life/observational studies that ...
1 CitationsSource
#1Yu Cheol Kim (KMU: Keimyung University)H-Index: 1
#2Jae Pil ShinH-Index: 17
Last. Ji Eun Lee (PNU: Pusan National University)H-Index: 19
view all 9 authors...
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 ...
2 CitationsSource