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

• Published in: Japanese journal of ophthalmology Vol. 65; no. 3; pp. 354 - 362
• Main 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
• Format: Journal Article
• Language: English
• Published: Tokyo Springer Japan 01.05.2021; Springer Nature B.V
• Subjects: Acuity; Clinical Investigation; Diabetes; Diabetes mellitus; Diabetic retinopathy; Edema; Eye; Eye (anatomy); Medicine; Medicine & Public Health; Ophthalmology; Patients; Visual acuity; Focal/grid photocoagulation; Aflibercept; Treat-and-extend; Diabetic macular edema
• ISSN: 0021-5155; 1613-2246
• DOI: 10.1007/s10384-021-00820-0

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.