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09.02.2021 | Clinical Investigation

Treat-and-extend therapy with aflibercept for diabetic macular edema: a prospective clinical trial

verfasst von: 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

Erschienen in: Japanese Journal of Ophthalmology | Ausgabe 3/2021

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Abstract

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-observation-carried-forward method. A per-protocol analysis was also performed for patients who completed a 1-year T&E regimen. The primary endpoints were mean changes in best-corrected visual acuity (BCVA) and central subfield macular thickness (CST) from baseline. Secondary endpoints included IAI-interval extension and resultant IAI numbers and the association between an early response to IAI and final BCVA gain at 1 year.

Results

Thirty-one patients (77.5%) completed the 1-year aflibercept T&E regimen. In these per-protocol participants, the mean CST improvement/reduction was 187.3 ± 145.0 µm (P < .001), but the mean BCVA gain was limited to 4.3 ± 12.2 letters (P = .782). Subanalysis revealed that eyes that gained ≥ 4 letters (median at week 12) after the initial 3 consecutive IAIs (induction phase) achieved greater vision improvement (13.8 ± 9.5 letters) than did the residual eyes (− 4.3 ± 9.2 letters) at 1 year (P < .001). Treatment intervals were extended to 12 and 16 weeks in 16.1% (5/31) and 45.2% (14/31) of the patients, respectively. The mean IAI number was 7.0 ± 1.1.

Conclusions

The results of this study suggest that although the BCVA improvement might be somewhat less than that of frequent treatment, a T&E aflibercept regimen with the longest treatment interval set to 16 weeks is a realizable rational strategy for DME treatment over 1 year.
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Metadaten
Titel
Treat-and-extend therapy with aflibercept for diabetic macular edema: a prospective clinical trial
verfasst von
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
Publikationsdatum
09.02.2021
Verlag
Springer Japan
Erschienen in
Japanese Journal of Ophthalmology / Ausgabe 3/2021
Print ISSN: 0021-5155
Elektronische ISSN: 1613-2246
DOI
https://doi.org/10.1007/s10384-021-00820-0

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