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A Phase I Study of GenSci148 Intravitreal Injection for Neovascular Age-related Macular Degeneration, Diabetic Macular Edema and Retinal Vein Occlusion
Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Summary
This is a Phase I, multicenter, open-label, dose-escalation study conducted in two parts to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GenSci148 administered via intravitreal (IVT) injection in participants with neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO). Part 1 evaluates single ascending doses in nAMD participants. Part 2 evaluates multiple doses in nAMD, DME, and RVO participants. The study also assesses immunogenicity and explores preliminary efficacy.
Official title: A Phase I, Open-label, Dose-escalation, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Intravitreal Injection of GenSci148 in Participants With Neovascular Age-related Macular Degeneration (nAMD) and Multiple Intravitreal Injections of GenSci148 in Participants With nAMD, Diabetic Macular Edema (DME) and Retinal Vein Occlusion (RVO)
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-09
Completion Date
2028-10
Last Updated
2026-09-14
Healthy Volunteers
No
Conditions
Interventions
GenSci148 Injection
GenSci148 is a fusion protein that simultaneously targets VEGF-A, VEGF-C, VEGF-D, and Ang-2.
Locations (1)
Shanghai General Hospital
Shanghai, Shanghai Municipality, China