Brolucizumab与新生血管性年龄相关性黄斑变性和Aflibercept参与者:一项随机试验。
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贾菲GJ, Dugel PU Sallstig P,沃伯顿J, Weichselberger,维兰德M, Singerman L
Brolucizumab与新生血管性年龄相关性黄斑变性和Aflibercept参与者:一项随机试验。
眼科学。2017年9月,124 (9):1296 - 1304。doi: 10.1016 / j.ophtha.2017.03.057。2017年5月24日Epub。
- PubMed ID
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28551167 (在PubMed]
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目的:比较疗效和安全性的brolucizumab aflibercept治疗新生血管性年龄相关性黄斑变性(AMD)。设计:前瞻性、随机、双盲、多中心2-arm,第二阶段的研究。参与者:八十九首次治疗参与者,> / = 50岁,活跃的脉络膜新生血管形成二级AMD。方法:符合条件的参与者随机1:1 intravitreal brolucizumab(6毫克/ 50 mul)或aflibercept(2毫克/ 50 mul)。两组收到3月负荷剂量,然后被对待每8周(处置)评估多达40周。brolucizumab组,最终处置周期延长,使2周期治疗每12周(12;周56);参与者在aflibercept继续游戏。非常规的治疗被允许在调查员的自由裁量权。主要结果测量:主要和次要的假设被非(保证金:5信1-sidedα水平0.1)在最佳矫正视力(BCVA)改变基线brolucizumab和aflibercept 12到16周,分别。 BCVA, central subfield thickness (CSFT), and morphologic features were assessed throughout the study. RESULTS: The mean BCVA change from baseline (letters) with brolucizumab was noninferior to aflibercept at week 12 (5.75 and 6.89, respectively [80% confidence interval for treatment difference, -4.19 to 1.93]) and week 16 (6.04 and 6.62 [-3.72 to 2.56]), with no notable differences up to week 40. Outcomes exploring disease activity during the q8 treatment cycles suggest greater stability of the brolucizumab participants, supported by receipt of fewer unscheduled treatments versus aflibercept (6 vs. 15) and more stable CSFT reductions. In addition, from post hoc analysis, a greater proportion of brolucizumab-treated eyes had resolved intraretinal and subretinal fluid compared with aflibercept-treated eyes. Approximately 50% of brolucizumab-treated eyes had stable BCVA during the q12 cycles. Brolucizumab and aflibercept adverse events were comparable. CONCLUSIONS: During the matched q8 phase, the BCVA in brolucizumab-treated eyes appeared comparable to aflibercept-treated eyes, with more stable CSFT reductions, receipt of fewer unscheduled treatments, and higher rates of fluid resolution. The brolucizumab safety profile was similar to aflibercept over 56 weeks of treatment. A 12-week treatment cycle for brolucizumab may be viable in a relevant proportion of eyes.
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