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. 2021 Feb 24;11(1):4488.
doi: 10.1038/s41598-021-83811-y.

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

Takao Hirano  1 , Yuichi Toriyama  2 , Yoshihiro Takamura  3 , Masahiko Sugimoto  4 , Taiji Nagaoka  5 , Yoshimi Sugiura  6 , Fumiki Okamoto  6 , Michiyuki Saito  7 , Kousuke Noda  7 , Shigeo Yoshida  8 , Akihiro Ishibazawa  9 , Osamu Sawada  10 , Toshinori Murata  2
Affiliations

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

Takao Hirano et al. Sci Rep. .

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.

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Conflict of interest statement

Akihiro Ishibazawa is a consultant for and receives research support from Optos and Carl Zeiss Meditec, serves as a consultant for Centervue, and has access to research instruments provided by Heidelberg Engineering, Topcon Medical Systems, Optos, Carl Zeiss Meditec, Nidek, and Centervue. Akihiro Ishibazawa reports lecture fees from Novaltis International AG, Santen Pharmaceutical Co., Ltd., Bayer Yakuhin, Ltd., and Kowa Pharma, Kousuke Noda reports grants from Novartis Pharma K.K. Masahiko Sugimoto reports personal fees from Novartis Pharma K.K., Bayer, Santen Pharmaceutical Co., Ltd., Senjyu Pharmaceutical Co., Ltd., Kowa Pharma, Daiichi Yakuhin Sangyo, and Wakamoto Pharmaceutical Co., Ltd., Osamu Sawada reports research supports from Novartis Phrama K.K., research support from Alcon, personal fees from Santen, personal fees from Novartis Novartis Phrama K.K., personal fees from Bayer, personal fees from Senju, and personal fees from Kowa. Shigeo Yoshida reports personal fees from Novartis Pharma K.K., grants and personal fees from Bayer, personal fees from Kowa Pharma., personal fees from Wakamoto Pharmaceutical Co., Ltd., grants and personal fees from Senjyu Pharmaceutical Co., Ltd., and grants and personal fees from Santen Pharmaceutical Co., Ltd. Takao Hirano reports personal fees from Novartis Pharma K.K., personal fees from Bayer, and personal fees from Carl Zeiss Meditec. Toshinori Murata reports grants from Bayer during the conduct of the study; personal fees from Novartis Pharma K.K., personal fees from Santen Pharma, personal fees from Bayer, and personal fees from Carl Zeiss Meditec. Yoshihiro Takamura reports personal fees from Novartis Pharma, Bayer, Santen, and Senju. Yuichi Toriyama reports personal fees from Novartis Pharma K.K. and personal fees from Carl Zeiss Meditec. Michiyuki Saito, Fumiki Okamoto, Taiji Nagaoka, and Yoshimi Sugiura declare no potential conflict of interest.

Figures

Figure 1
Figure 1
Change in the mean best-corrected visual acuity. Change in the mean best-corrected visual acuity (BCVA; Early Treatment Diabetic Retinopathy Study letters) in (A) full analysis set (all participants and those with baseline BCVA of 24–73 letters) and (B) per-protocol set (all participants and those with baseline BCVA of 24–73 letters). Missing values are imputed using the “Last Observation Carried Forward” method.
Figure 2
Figure 2
Graphs illustrating individual changes in best corrected visual acuity letter score (Early Treatment Diabetic Retinopathy Study: ETDRS). Each bar corresponds to an individual patient.
Figure 3
Figure 3
Change in the mean central macular thickness. Change in the mean central macular thickness (CST) in (A) full analysis set (all participants and those with baseline BCVA of 24–73 letters) and (B) per-protocol set (all participants and those with baseline BCVA of 24–73 letters). Missing values are imputed using the “last observation carried forward” method.
Figure 4
Figure 4
Distribution of various treatment intervals (8 weeks, 12 weeks, and 16 weeks) after 1 and 2 years.
See this image and copyright information in PMC

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