[Translation] A randomized, double-blind, parallel-group, positive-controlled phase I clinical trial comparing the safety, pharmacokinetics, and pharmacodynamics of JZB05 and aflibercept in patients with diabetic macular edema
主要目的:
1、比较糖尿病黄斑水肿(DME)患者玻璃体腔单次注射JZB05和阿柏西普的临床安全性。
2、比较糖尿病黄斑水肿(DME)患者玻璃体腔单次注射JZB05和阿柏西普的系统药代动力学(PK)特征;
次要目的:
探索糖尿病黄斑水肿(DME)患者玻璃体腔单次注射JZB05后的初步疗效。
[Translation] Main objectives:
1. To compare the clinical safety of a single intravitreal injection of JZB05 and aflibercept in patients with diabetic macular edema (DME).
2. To compare the systemic pharmacokinetic (PK) characteristics of a single intravitreal injection of JZB05 and aflibercept in patients with diabetic macular edema (DME);
Secondary objectives:
To explore the preliminary efficacy of a single intravitreal injection of JZB05 in patients with diabetic macular edema (DME).