[Translation] A multicenter, randomized, double-blind, parallel-controlled clinical trial comparing the efficacy, safety, and pharmacokinetic characteristics of HJY28 and Lucentis® in the treatment of Chinese patients with wet age-related macular degeneration
试验主要目的为评价HJY28和诺适得®治疗湿性年龄相关性黄斑变性16周的疗效相似性。次要目的为比较HJY28和诺适得®治疗湿性年龄相关性黄斑变性52周的安全性和免疫原性;考察HJY28的临床药理学特征,并比较中国湿性年龄相关性黄斑变性患者玻璃体注射HJY28或诺适得 ®的药代动力学特征。
[Translation] The primary objective of the trial is to evaluate the similarity of the efficacy of HJY28 and Lusitadin® in the treatment of wet age-related macular degeneration for 16 weeks. The secondary objectives are to compare the safety and immunogenicity of HJY28 and Lusitadin® in the treatment of wet age-related macular degeneration for 52 weeks; to investigate the clinical pharmacological characteristics of HJY28, and to compare the pharmacokinetic characteristics of HJY28 or Lusitadin® injected into the vitreous of Chinese patients with wet age-related macular degeneration.