Prospective Trial of Treat-and-Extend versus Monthly Dosing for Neovascular Age-Related Macular Degeneration TREX-AMD 1-Year Results-猫眼课题宝

DOI：

10.1016/j.ophtha.2015.08.009

发表时间：

2015-12-01

期刊：

OPHTHALMOLOGY

影响因子：

13.7

通讯作者：

中科院分区：

医学1区

文献类型：

作者：

Wykoff, Charles C.;Croft, Daniel E.;Sadda, SriniVas R.

目的：前瞻性评价治疗初期新生血管性老年性黄斑变性(AMD)患者玻璃体内注射雷尼比单抗(TREX)和每月注射雷尼比单抗(TREX)的治疗策略。设计：IIIb期多中心随机对照临床试验。参与者：60名未接受治疗的新生AMD患者按1：2随机分为每月或TREX治疗组。方法：早期治疗糖尿病视网膜病变研究(ETDRS)最佳矫正视力(BCVA)为20/32至20/500(相当于Snellen)的患者随机分为活体内注射雷尼比单抗0.5 mg或每月接受TREX治疗。TREX患者每月至少接受3次治疗，直到临床和光谱域光学相干断层扫描显示渗出性疾病活动的证据消失；然后根据严格的前瞻性方案个体化就诊间隔。主要观察指标：平均ETDRS BCVA较基线变化。结果：基线时平均年龄77岁(范围59-96岁)，平均BCVA为20/60(相当于Snellen)，平均中心视网膜厚度(CRT)为511 mm。57只眼(95%)完成了12个月的治疗，平均BCVA在每月组和TREX组分别提高了9.2和10.5个字母(P=0.60)。在每月和TREX队列中，12个月的平均注射次数分别为13.0次和10.1次(范围为7-13次)(P&lt；0.0001)。在TREX患者中，7例(18%)达到最大延长，4例(10%)每次就诊时出现液体，12个月时，18例(45%)达到延长间隔8周或以上，前3次注射后平均最大延长间隔为8.4周(4~12周)。大多数复发渗出性疾病活动的TREX患者(17/24[71%])无法超过最初的最大延长间期。结论：在这项前瞻性、随机、对照试验中使用的TREX新生血管AMD管理策略导致的视觉和解剖学收益与每月给药获得的结果相当。眼科2015；美国眼科学会122：2514-2522(C)2015。这是CC BY-NC-ND License(http://creativecommons.org/licenses/by-nc-nd/4.0/).下的一篇开放获取文章

Purpose: To assess prospectively a treat-and-extend (TREX) management strategy compared with monthly dosing of intravitreal ranibizumab in treatment-naive neovascular age-related macular degeneration (AMD) patients.Design: Phase IIIb, multicenter, randomized, controlled clinical trial.Participants: Sixty patients with treatment-naive neovascular AMD randomized 1: 2 to monthly or TREX management.Methods: Patients with Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) from 20/32 to 20/500 (Snellen equivalent) were randomized to receive intravitreal 0.5 mg ranibizumab monthly or according to a TREX protocol. The TREX patients were treated monthly for at least 3 doses, until resolution of clinical and spectral-domain optical coherence tomography evidence of exudative disease activity; the interval between visits then was individualized according to a strict prospective protocol.Main Outcome Measures: Mean ETDRS BCVA change from baseline.Results: At baseline, mean age was 77 years (range, 59-96 years), mean BCVA was 20/60 (Snellen equivalent), and mean central retinal thickness (CRT) was 511 mm. Fifty-seven eyes (95%) completed month 12, at which point mean BCVA improved by 9.2 and 10.5 letters in the monthly and TREX cohorts, respectively (P = 0.60). The mean number of injections administered through month 12 was 13.0 and 10.1 (range, 7-13) in the monthly and TREX cohorts, respectively (P < 0.0001). Among TREX patients, 7 (18%) were maximally extended, 4 (10%) demonstrated fluid at every visit, and at month 12, 18 (45%) had achieved an extension interval of 8 weeks or more; the mean maximum extension interval between injections after the first 3 monthly doses was 8.4 weeks (range, 4-12 weeks). Most TREX patients who demonstrated recurrent exudative disease activity (17/24 [ 71%]) were unable to extend beyond their initial maximum extension interval.Conclusions: The TREX neovascular AMD management strategy used in this prospective, randomized, controlled trial resulted in visual and anatomic gains comparable with those obtained with monthly dosing. Ophthalmology 2015; 122:2514-2522 (C) 2015 by the American Academy of Ophthalmology. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Prospective Trial of Treat-and-Extend versus Monthly Dosing for Neovascular Age-Related Macular Degeneration TREX-AMD 1-Year Results

文献摘要

被引文献

相似文献