[Translation] A Phase I/II Dose-Escalation, Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Intravitreal OCUL101 in Patients with Neovascular Age-Related Macular Degeneration, Diabetic Macular Edema, and Geographic Atrophy Secondary to Age-Related Macular Degeneration
Ⅰ期:即研究的第1部分和第2部分,评估玻璃体内注射(IVT)OCUL101 在新生血管性年龄相关性黄斑变性(nAMD)安全性、耐受性。
Ⅱ期:即研究的第3部分,评估OCUL101 在新生血管性年龄相关性黄斑变性(nAMD)、糖尿病性黄斑水肿(DME) 和继发于年龄相关性黄斑变性的地图样萎缩GA患者的代动力学(PK)、药效学(PD)和初步疗效。
[Translation] Phase I: Part 1 and Part 2 of the study, evaluating the safety and tolerability of intravitreal injection (IVT) of OCUL101 in neovascular age-related macular degeneration (nAMD).
Phase II: Part 3 of the study, evaluating the pharmacokinetic (PK), pharmacodynamics (PD) and preliminary efficacy of OCUL101 in patients with neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME) and geographic atrophy secondary to age-related macular degeneration (GA).