Retinal Consultants of Arizona, Phoenix, Arizona.
Asan Medical Center, University of Ulsan, Seoul, South Korea.
Ophthalmology. 2020 Oct;127(10):1331-1344. doi: 10.1016/j.ophtha.2020.03.035. Epub 2020 Apr 9.
To compare the efficacy and safety of abicipar every 8 weeks and quarterly (after initial doses) versus ranibizumab every 4 weeks in treatment-naïve patients with neovascular age-related macular degeneration (AMD).
Two randomized, multicenter, double-masked, parallel-group, active-controlled, phase 3 clinical trials (CEDAR, SEQUOIA) with identical protocols were conducted. Data from both trials were pooled for analysis.
Patients with active choroidal neovascularization secondary to AMD and best-corrected visual acuity (BCVA) of 24-73 Early Treatment Diabetic Retinopathy Study letters in the study eye were enrolled.
Patients (n = 1888) were randomized in a 1:1:1 ratio to study eye treatment with abicipar 2 mg every 8 weeks after 3 initial doses at baseline and weeks 4 and 8 (Q8), abicipar 2 mg every 12 weeks after 3 initial doses at baseline and weeks 4 and 12 (Q12), or ranibizumab 0.5 mg every 4 weeks (Q4).
The primary efficacy end point was proportion of patients with stable vision (defined as <15-letter loss in BCVA from baseline) in the study eye at week 52. Secondary end points included change from baseline in BCVA and central retinal thickness (CRT) at week 52. Safety measures included adverse events (AEs).
The proportion of patients with stable vision at week 52 was 93.2%, 91.3%, and 95.8% in the abicipar Q8, abicipar Q12, and ranibizumab Q4 groups, respectively, with both abicipar Q8 and Q12 noninferior to ranibizumab Q4. Week 52 mean change from baseline in BCVA was 7.5, 6.4, and 8.4 letters and in CRT was -144, -145, and -144 μm in the abicipar Q8, abicipar Q12, and ranibizumab Q4 groups, respectively. Incidence of intraocular inflammation (IOI) AEs was 15.4%, 15.3%, and 0.3%, respectively. The IOI AEs were typically mild or moderate in severity and treated with topical corticosteroids; 62 of 192 patients (32.3%) received oral and/or injectable corticosteroids.
Abicipar Q8 and Q12 were both noninferior to ranibizumab Q4 in the primary end point of stable vision at week 52. Intraocular inflammation was more frequent with abicipar. Quarterly and Q8 abicipar reduce nAMD disease and treatment burden compared with monthly treatment.
比较贝伐单抗每 8 周（初始剂量后每 3 个月）和雷珠单抗每 4 周治疗初治新生血管性年龄相关性黄斑变性（AMD）患者的疗效和安全性。
进行了两项随机、多中心、双盲、平行分组、活性对照、3 期临床试验（CEDAR、SEQUOIA），方案完全相同。对两项试验的数据进行了汇总分析。
患有由 AMD 引起的脉络膜新生血管化和研究眼最佳矫正视力（BCVA）为 24-73 早期糖尿病视网膜病变研究字母的患者入选。
患者（n=1888）以 1:1:1 的比例随机分配至研究眼治疗，贝伐单抗 2mg 每 8 周（基线和第 4 周、第 8 周给予 3 个初始剂量后）、贝伐单抗 2mg 每 12 周（基线和第 4 周、第 12 周给予 3 个初始剂量后）或雷珠单抗 0.5mg 每 4 周（Q4）。
主要疗效终点为治疗 52 周时研究眼视力稳定（定义为 BCVA 较基线下降<15 个字母）的患者比例。次要终点包括治疗 52 周时 BCVA 和中央视网膜厚度（CRT）的变化。安全性测量包括不良事件（AE）。
贝伐单抗 8 周和 12 周组治疗 52 周时视力稳定的患者比例分别为 93.2%、91.3%和 95.8%，贝伐单抗 8 周和 12 周均不劣于雷珠单抗 Q4。治疗 52 周时 BCVA 平均变化较基线分别为 7.5、6.4 和 8.4 个字母，CRT 分别为-144、-145 和-144μm。眼内炎症（IOI）AE 的发生率分别为 15.4%、15.3%和 0.3%。IOI AE 通常为轻度或中度，经局部皮质类固醇治疗；192 例患者中有 62 例（32.3%）接受了口服和/或注射皮质类固醇治疗。
贝伐单抗 8 周和 12 周在第 52 周主要终点视力稳定方面均不劣于雷珠单抗 Q4。贝伐单抗更频繁发生眼内炎症。与每月治疗相比，每 3 个月和每 8 周的贝伐单抗可减少 nAMD 疾病和治疗负担。
