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- Title
Treat-and-extend therapy with aflibercept for diabetic macular edema: a prospective clinical trial.
- Authors
Hirano, Takao; Toriyama, Yuichi; Takamura, Yoshihiro; Sugimoto, Masahiko; Nagaoka, Taiji; Sugiura, Yoshimi; Okamoto, Fumiki; Saito, Michiyuki; Noda, Kousuke; Yoshida, Shigeo; Ishibazawa, Akihiro; Sawada, Osamu; Murata, Toshinori
- 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.
- Subjects
DIABETIC retinopathy; VISION; CLINICAL trials; EDEMA; INTRAVITREAL injections; VISUAL acuity; AFLIBERCEPT
- Publication
Japanese Journal of Ophthalmology, 2021, Vol 65, Issue 3, p354
- ISSN
0021-5155
- Publication type
Article
- DOI
10.1007/s10384-021-00820-0