Palmetto Retina Center, West Columbia, South Carolina, USA
Blanton Eye Institute, Houston Methodist Hospital and Weill Cornell Medical College, Retina Consultants of Houston, Houston, Texas, USA.
Br J Ophthalmol. 2021 Feb;105(2):253-257. doi: 10.1136/bjophthalmol-2020-316176. Epub 2020 Apr 17.
BACKGROUND/AIMS: To evaluate the long-term effects of treat-and-extend dosing of ranibizumab with and without navigated focal laser for diabetic macular oedema (DME).
This is a multicentre, randomised clinical trial where 150 eyes were randomised into three cohorts; Monthly (n=30), TReat and EXtend without macular laser photocoagulation (TREX; n=60), and treat and extend with angiography-GuIded macular LAser photocoagulation (GILA; n=60). During the first 2 years, eyes either received ranibizumab 0.3 mg every 4 weeks or underwent treat-and-extend ranibizumab with or without angiography-guided laser therapy. In the third year, all eyes were treated as needed with ranibizumab for >5 letters vision loss or if the central retinal thickness (CRT) was >325 µm, and all eyes were eligible to receive focal laser.
109 eyes (73%) completed the 3-year end-point. At week 156, mean best-corrected visual acuity (BCVA) and CRT improved by 6.9, 9.7, 9.5 letters (p=0.60) and 129, 138, 165 µm (p=0.39), in the Monthly, TREX and GILA cohorts, respectively. These improvements were reached prior to week 104 and no significant changes occurred from week 104 to week 156 (BCVA: p=0.34; CRT: p=0.36). The mean number of injections in the third year was 3.0, 3.1, and 2.4 in the Monthly, TREX and GILA cohorts, respectively (p=0.56). 86 eyes (79%) required at least one ranibizumab injection in the third year.
The improvements achieved after 2 years of treat-and-extend ranibizumab for DME were maintained in the third year with a mean of 3 intravitreal injections.
FDA IND 119146, NCT01934556.
背景/目的：评估雷珠单抗治疗和延伸剂量治疗糖尿病黄斑水肿（DME）时联合和不联合导航局灶性激光的长期效果。
这是一项多中心、随机临床试验，其中 150 只眼随机分为三组；每月治疗组（n=30）、不联合黄斑激光光凝的治疗和延伸组（TREX；n=60）和联合血管造影引导的黄斑激光光凝的治疗和延伸组（GILA；n=60）。在前 2 年内，眼要么接受雷珠单抗 0.3mg 每 4 周一次，要么接受治疗和延伸雷珠单抗治疗，联合或不联合血管造影引导的激光治疗。在第 3 年，所有眼均根据需要接受雷珠单抗治疗，以防止视力丧失超过 5 个字母或中央视网膜厚度（CRT）大于 325μm，如果 CRT 大于 325μm，则所有眼都有资格接受局灶性激光治疗。
109 只眼（73%）完成了 3 年的终点。在第 156 周时，每月、TREX 和 GILA 组的平均最佳矫正视力（BCVA）和 CRT 分别提高了 6.9、9.7 和 9.5 个字母（p=0.60）和 129、138 和 165μm（p=0.39）。这些改善在第 104 周之前就已经达到，并且从第 104 周到第 156 周没有发生显著变化（BCVA：p=0.34；CRT：p=0.36）。在第 3 年，每月、TREX 和 GILA 组的平均注射次数分别为 3.0、3.1 和 2.4（p=0.56）。第 3 年，86 只眼（79%）至少需要进行一次雷珠单抗注射。
在接受 2 年的治疗和延伸雷珠单抗治疗 DME 后，在第 3 年，平均注射 3 次即可保持改善。
FDA IND 119146，NCT01934556。
