[Translation] A randomized, double-blind, parallel-controlled Phase I study comparing the safety, immunogenicity, pharmacokinetics, pharmacodynamics, and preliminary efficacy of CMAB818 injection versus Novostat® in patients with wet age-related macular degeneration .
主要目的:评价CMAB818 注射液和诺适得®在wAMD 患者目标眼单次(0.5 mg)玻璃体内注射的安全性;
次要目的: 评价CMAB818 注射液和诺适得®在wAMD 患者目标眼单次(0.5 mg)玻璃体内注射的免疫原性、药代动力学特征和药效学特征; 评价CMAB818 注射液和诺适得®在wAMD 患者目标眼单次(0.5 mg)玻璃体内注射的临床初步疗效。
[Translation] Main objective: To evaluate the safety of a single (0.5 mg) intravitreal injection of CMAB818 injection and Novostat® in the target eye of wAMD patients;
Secondary Objectives: To evaluate the immunogenicity, pharmacokinetics and pharmacodynamics of a single (0.5 mg) intravitreal injection of CMAB818 injection and Novostat® in the target eye of wAMD patients; to evaluate CMAB818 injection and Novozymes Preliminary clinical efficacy of a single (0.5 mg) intravitreal injection of Dexed® in the target eye of wAMD patients.