[Translation] A prospective, randomized, double-blind, active-controlled, multicenter, two-arm, phase III study to evaluate the efficacy and safety of intravitreal KSI-301 compared with intravitreal aflibercept in treatment-naïve subjects with visual impairment secondary to diabetic macular edema (DME)
主要目的: 证明KSI-301 5 mg在研究第1天至第1年(第48周和第52周的平均值)后达到的BCVA平均变化不劣于阿柏西普2 mg。
次要目的: 通过评估视力参数,评价研究期间KSI-301 5 mg 相较于阿柏西普2 mg的疗效。通过评估解剖参数,评价研究期间KSI-301 5 mg 相较于阿柏西普2 mg的疗效。评估研究期间,KSI-301 5 mg相较于阿柏西普2 mg的疗效持久性。评估KSI-301 5 mg相较于阿柏西普2 mg的安全性 和耐受性。
[Translation] Primary Objective: To demonstrate that KSI-301 5 mg is non-inferior to aflibercept 2 mg in achieving mean change in BCVA from study day 1 to year 1 (average of weeks 48 and 52).
Secondary Objectives: To evaluate the efficacy of KSI-301 5 mg compared to aflibercept 2 mg during the study by assessing visual parameters. To evaluate the efficacy of KSI-301 5 mg compared to aflibercept 2 mg during the study by assessing anatomical parameters. To assess the durability of the efficacy of KSI-301 5 mg compared to aflibercept 2 mg during the study. To assess the safety and tolerability of KSI-301 5 mg compared to aflibercept 2 mg.