Department of Ophthalmology, Keimyung University School of Medicine, Daegu, Korea.
Department of Ophthalmology, Kyungpook National University School of Medicine, Daegu, Korea.
Sci Rep. 2020 Dec 16;10(1):22030. doi: 10.1038/s41598-020-78954-3.
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 CSMT was stable. The number of injections, best-corrected visual acuity (BCVA), CSMT, and diabetic retinopathy severity scale scores were analysed. Compared to baseline, BCVA improved by + 9.1 letters at 52 weeks and was maintained with + 9.4-letter gain at 104 weeks (P < 0.001). Between baseline and 104 weeks, CSMT decreased from 489 to 298 μm (P < 0.001) and eyes with vision ≥ 20/40 increased from 17.4 to 43.5% (P = 0.007). The mean number of injections decreased from 8.5 in year one to 3.9 in year two. The injection interval was extended to ≥ 12 weeks in 56.5% of patients. The treat-and-extend regimen of aflibercept in DME showed 2-year efficacy comparable to that of fixed dosing regimens. The flexible dosing of this regimen reduced the number of injections in year two while maintaining efficacy.
本研究旨在探讨阿柏西普治疗糖尿病黄斑水肿（DME）的“治疗-延长”方案的疗效。这是一项前瞻性、多中心、干预性、单臂、104 周临床试验，纳入了 48 例 DME 视力受损患者。患者的眼睛每四周接受连续五次玻璃体内注射（2mg 阿柏西普），根据中央视网膜神经纤维层厚度（CSMT）变化进行两周调整。当 CSMT 稳定时，将推迟注射。分析了注射次数、最佳矫正视力（BCVA）、CSMT 和糖尿病视网膜病变严重程度评分。与基线相比，52 周时 BCVA 提高了+9.1 个字母，104 周时保持了+9.4 个字母的增益（P<0.001）。在基线和 104 周之间，CSMT 从 489μm 降至 298μm（P<0.001），视力≥20/40 的眼睛比例从 17.4%增加到 43.5%（P=0.007）。注射次数从第一年的 8.5 次减少到第二年的 3.9 次。在 56.5%的患者中，注射间隔延长至≥12 周。阿柏西普在 DME 中的“治疗-延长”方案显示出与固定剂量方案相当的 2 年疗效。该方案的灵活剂量在第二年减少了注射次数，同时保持了疗效。
