[Translation] An exploratory phase I/II clinical trial of the tolerability, safety, and efficacy of KH631 ophthalmic injection in patients with neovascular (wet) age-related macular degeneration (nAMD).
1期主要评估视网膜下注射不同剂量KH631眼用注射液在新生血管性(湿性)年龄相关性黄斑变性(nAMD)患者中的耐受性,初步评估KH631眼用注射液治疗nAMD的疗效,主要在24周评估总体安全性。2期主要根据1期耐受性、安全性和初步疗效评估的结果,选择2期推荐剂量组扩大样本量评估KH631眼用注射液在nAMD患者中的疗效和安全性,主要在52周评估有效性。长期随访期目的为在已接受KH631眼用注射液视网膜下注射的患者中评估KH631眼用注射液的长期安全性和有效性。
[Translation] Phase 1 mainly evaluates the tolerability of subretinal injection of different doses of KH631 ophthalmic injection in patients with neovascular (wet) age-related macular degeneration (nAMD), preliminarily evaluates the efficacy of KH631 ophthalmic injection in the treatment of nAMD, and mainly evaluates overall safety at 24 weeks. Phase 2 mainly selects the Phase 2 recommended dose group to expand the sample size to evaluate the efficacy and safety of KH631 ophthalmic injection in patients with nAMD based on the results of Phase 1 tolerability, safety and preliminary efficacy evaluation, and mainly evaluates effectiveness at 52 weeks. The purpose of the long-term follow-up period is to evaluate the long-term safety and efficacy of KH631 ophthalmic injection in patients who have received subretinal injection of KH631 ophthalmic injection.