Treat-and-Extend versus Monthly Regimen in Neovascular Age-Related Macular Degeneration Results with Ranibizumab from the TREND Study
Treat-and-Extend versus Monthly Regimen in Neovascular Age-Related Macular Degeneration Results with Ranibizumab from the TREND Study
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DOI：
10.1016/j.ophtha.2017.07.014
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发表时间：
2018-01-01
期刊：
影响因子：
13.7
通讯作者：
Mones, Jordi
中科院分区：
文献类型：
--
作者：
Silva, Rufino;Berta, Andras;Mones, Jordi
目的：从治疗和延长(趋势)研究中评价雷比珠单抗0.5 mg治疗和延长(T&E)与每月方案治疗新生血管性老年性黄斑变性(NAMD)的疗效和安全性。设计：一项为期12个月的3b期视力(VA)评估，多中心，随机，干预研究。参与者：650名患者。=50岁)随机接受雷比珠单抗0.5mgT&E方案(n=323)或每月方案(n=327)。主要结果指标：主要目标是显示雷尼比单抗0.5mgT&E与每月方案相比的非劣性，通过从基线到研究结束时最佳矫正视力(BCVA)的变化来评估。次要目标包括从基线到研究结束时视网膜中央亚区厚度(CSFT)的变化、治疗暴露和安全性。结果：总体而言，89.8%(T&E)和90.2%(每月)的患者完成了研究。患者的人口统计和基线特征在两个治疗组之间很好地平衡。T&E方案并不比每月方案差(P<；0.001)，从基线到研究结束，平均BCVA的变化分别为6.2%和8.1%。在两个治疗组中，大多数BCVA的改善发生在前6个月，并一直保持到研究结束。从基线到研究结束，T&E组和月度组CSFT的平均变化分别为169.2 mm和173.3 mm。接受T&E(8.7)和每月(11.1)方案的患者需要的注射较少，平均基线后就诊次数分别为8.9次和11.2次。两组不良事件的类型和发生率具有可比性。结论：从基线到研究结束，按T&E方案服用雷尼比单抗0.5 mg在统计学上非劣势，在临床上与每月一次的方案相似。没有发现雷尼比珠单抗的新安全信号。(C)2017美国眼科学会。由爱思唯尔公司出版。
Purpose: To evaluate the efficacy and safety of ranibizumab 0.5 mg treat-and-extend (T& E) versus monthly regimens in patients with neovascular age-related macular degeneration (nAMD) from the TReat and extEND (TREND) study.Design: A 12-month phase 3b visual acuity (VA) assessor-masked, multicenter, randomized, interventional study.Participants: Six hundred fifty patients.Methods: Treatment-naive nAMD patients (age, >= 50 years) were randomized 1: 1 to receive either a ranibizumab 0.5 mg T& E (n = 323) or monthly (n = 327) regimen.Main Outcomes Measures: The primary objective was to show noninferiority of ranibizumab 0.5 mg T& E versus monthly regimen, as assessed by the change in best-corrected VA (BCVA) from baseline to the end of the study. Secondary objectives included change in retinal central subfield thickness (CSFT) from baseline to the end of study, treatment exposure, and safety.Results: Overall, 89.8% (T& E) and 90.2% (monthly) of patients completed the study. Patient demographic and baseline characteristics were well balanced between the 2 treatment groups. The T& E regimen was noninferior (P < 0.001) to the monthly regimen, with a least squares mean BCVA change from baseline of 6.2 versus 8.1 letters to the end of study, respectively. In both treatment groups, most BCVA improvements occurred during the first 6 months and were maintained until the end of the study. The mean change in CSFT from baseline to the end of study was 169.2 mm and 173.3 mm in the T& E and monthly groups, respectively. Fewer injections were required in patients receiving the T& E (8.7) versus monthly (11.1) regimen, with mean number of postbaseline visits of 8.9 and 11.2, respectively. Types and rates of adverse events were comparable between the treatment groups.Conclusions: Ranibizumab 0.5 mg administered according to a T& E regimen was statistically noninferior and clinically comparable with a monthly regimen in improving VA from baseline to the end of study. No new safety signals for ranibizumab were identified. (C) 2017 American Academy of Ophthalmology. Published by Elsevier Inc.