Arai Yusuke, Takahashi Hidenori, Inoda Satoru, Sakamoto Shinichi, Tan Xue, Kawashima Hidetoshi, Yanagi Yasuo
Department of Ophthalmology, Jichi Medical University, 3311-1 Yakushiji, Shimotsuke City 329-0498, Tochigi, Japan.
Japan Community Health Care Organization Tokyo Shinjuku Medical Center, 5-1 Tsukudocho, Shinjuku-ku, Tokyo 162-8543, Japan.
J Clin Med. 2023 Aug 2;12(15):5089. doi: 10.3390/jcm12155089.
This prospective, multicentre, interventional study evaluated the efficacy of a modified treat-and-extend (mTAE) aflibercept regimen as personalized therapy for macular oedema (MO) due to central retinal vein occlusion (CRVO). Fifty eyes were studied from 50 patients who were enrolled between November 2016 and July 2019. All patients received intravitreal aflibercept (IVA) injections on an mTAE regimen for 24 months. Primary outcome measures were best-corrected visual acuity (BCVA) and central subfield thickness (CST) at 12 months. Secondary endpoints were BCVA and CST at 24 months. Mean (standard deviation) baseline BCVA (logMAR) and CST were 0.50 (0.51) and 557 (240) µm, respectively. BCVA and CST showed significant improvements at month 12 (0.19 (0.38) and 275 (98) µm, respectively; both < 0.0001, paired -test). BCVA and CST also showed significant improvements at 24 months (0.26 (0.50) and 255 (91) µm, respectively, = 0.0004 and < 0.0001, paired -test). The mean numbers of IVA injections and clinic visits over the 24-month study period were 6.2 (3.0) and 10.3 (1.0), respectively. The mTAE regimen of IVA injections for MO due to CRVO was effective in improving BCVA and decreasing CST at 24 months. The mTAE regimen might be an effective personalized therapy for CRVO.
这项前瞻性、多中心、干预性研究评估了改良型治疗与延长（mTAE）阿柏西普方案作为视网膜中央静脉阻塞（CRVO）所致黄斑水肿（MO）个性化治疗的疗效。对2016年11月至2019年7月期间纳入的50例患者的50只眼睛进行了研究。所有患者均按照mTAE方案接受玻璃体内注射阿柏西普（IVA），为期24个月。主要结局指标为12个月时的最佳矫正视力（BCVA）和中心子野厚度（CST）。次要终点为24个月时的BCVA和CST。平均（标准差）基线BCVA（logMAR）和CST分别为0.50（0.51）和557（240）µm。BCVA和CST在第12个月时均有显著改善（分别为0.19（0.38）和275（98）µm；均P<0.0001，配对t检验）。BCVA和CST在24个月时也有显著改善（分别为0.26（0.50）和255（91）µm，P=0.0004和P<0.0001，配对t检验）。在24个月的研究期间，IVA注射的平均次数和门诊就诊次数分别为6.2（3.0）和10.3（1.0）。CRVO所致MO的IVA注射mTAE方案在24个月时可有效改善BCVA并降低CST。mTAE方案可能是CRVO的一种有效的个性化治疗方法。
