[Translation] A phase I/II clinical trial evaluating the safety, pharmacokinetic characteristics, and preliminary efficacy of SQ-129 intravitreal sustained-release injection for macular edema caused by branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).
主要目的:探索SQ-129玻璃体缓释注射液用于视网膜分支静脉阻塞(BRVO)或中央静脉阻塞(CRVO)引起的黄斑水肿的安全性和初步疗效,为后续临床研究方案设计提供依据。次要目的:探索SQ-129玻璃体缓释注射液用于视网膜分支静脉阻塞(BRVO)或中央静脉阻塞(CRVO)引起的黄斑水肿的药代动力学(PK)特征。
[Translation] Primary objective: To investigate the safety and preliminary efficacy of SQ-129 intravitreal sustained-release injection for macular edema caused by branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO), providing a basis for the design of subsequent clinical research protocols. Secondary objective: To investigate the pharmacokinetic (PK) characteristics of SQ-129 intravitreal sustained-release injection for macular edema caused by branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).