目的:为了评估疗效,安全,SB15与参照阿柏西普(AFL)的药代动力学(PK)和免疫原性,新生血管性年龄相关性黄斑变性(nAMD)从AFL转换为SB15。
方法:前瞻性,双面蒙面,随机化,第三阶段试验。
方法:nAMD参与者以1:1的比例随机接受SB15(N=224名参与者)或AFL(N=225)。在第32周,参与者继续使用SB15(SB15/SB15,N=219)或AFL(AFL/AFL,N=108),或从AFL切换到SB15(AFL/SB15,N=111)。本手稿报告了次要疗效终点的1年和转换结果,例如最佳矫正视力(BCVA)从基线到第56周的变化,中心子场厚度(CST,从内界膜(ILM)到视网膜色素上皮),和总视网膜厚度(TRT,从ILM到布鲁赫膜)。其他终点包括安全性,PK和免疫原性。
结果:两组之间的疗效结果相当。BCVA从基线到第56周的最小二乘平均值(LSmean)变化对于SB15/SB15为7.4个字母,对于AFL/AFL为7.0个字母(差异(95%CI)=0.4(-2.5至3.2))。CST和TRT从基线到第56周的LSmean变化对于SB15/SB15为-119.2µm和-132.4µm,对于AFL/AFL为-126.6µm和-136.3µm,分别(CST:差异(95%CI)=7.4µm(-6.11至20.96);TRT:差异(95%CI)=3.9µm(-18.35至26.10))。从基线到第56周,切换和未切换的参与者在BCVA中显示出相似的LSmean变化(AFL/SB15,7.9个字母与AFL/AFL,7.8个字母;差异(95%CI)=0.0(-2.8至2.8))。安全,组间PK和免疫原性相当。
结论:疗效,安全,PK和免疫原性在SB15和AFL之间以及在转换和非转换参与者之间是相当的。
To evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity of SB15 versus reference aflibercept (AFL), and switching from AFL to SB15 in neovascular age-related macular degeneration (nAMD).
Prospective, double-masked, randomised, phase 3
trial.
Participants with nAMD were randomised 1:1 to receive SB15 (N=224 participants) or AFL (N=225). At week 32, participants either continued on SB15 (SB15/SB15, N=219) or AFL (AFL/AFL, N=108), or switched from AFL to SB15 (AFL/SB15, N=111). This manuscript reports 1-year and switching results of secondary efficacy endpoints such as changes from baseline to week 56 in best-corrected visual acuity (BCVA), central subfield thickness (CST, from internal limiting membrane (ILM) to retinal pigment epithelium), and total retinal thickness (TRT, from ILM to Bruch\'s membrane). Additional endpoints included safety, PK and immunogenicity.
Efficacy results were comparable between groups. The least squares mean (LSmean) change in BCVA from baseline to week 56 was 7.4 letters for SB15/SB15 and 7.0 letters for AFL/AFL (difference (95% CI)=0.4 (-2.5 to 3.2)). The LSmean changes from baseline to week 56 in CST and TRT were -119.2 µm and -132.4 µm for SB15/SB15 and -126.6 µm and -136.3 µm for AFL/AFL, respectively (CST: difference (95% CI)=7.4 µm (-6.11 to 20.96); TRT: difference (95% CI)=3.9 µm (-18.35 to 26.10)). Switched and non-switched participants showed similar LSmean changes in BCVA from baseline to week 56 (AFL/SB15, 7.9 letters vs AFL/AFL, 7.8 letters; difference (95% CI)=0.0 (-2.8 to 2.8)). Safety, PK and immunogenicity were comparable between groups.
Efficacy, safety, PK and immunogenicity were comparable between SB15 and AFL and between switched and non-switched participants.