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.
Able to understand the study and provide written informed consent prior to any study-related procedures.
Willing and able to comply with scheduled visits, treatment plan, and study procedures.
Best corrected visual acuity (BCVA) of 24 to 78 letters (inclusive) in the study eye, and BCVA ≥ 24 letters in the fellow eye.
Prior or current contraindicated ophthalmic treatments in study or fellow eye per protocol.
Refractive error > ±8.0 diopters in the study eye.
Anterior segment neovascularization or vitreous hemorrhage in the study eye.
Single group
GenSci148 Injection
DrugGenSci148 is a fusion protein that simultaneously targets VEGF-A, VEGF-C, VEGF-D, and Ang-2.
Incidence and severity of treatment-emergent adverse events (TEAEs)
TEAEs include ocular and systemic adverse events, graded by severity and relationship to study drug. Safety assessments include physical examination, vital signs, laboratory tests, ECG, and ophthalmic examinations.
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This trial is not recruiting at the moment. You can still explore other options:
