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Clinical Trials in China / NCT07817615
Starting soon Phase 1

A Phase I Study of GenSci148 Intravitreal Injection for Neovascular Age-related Macular Degeneration, Diabetic Macular Edema and Retinal Vein Occlusion

NCT07817615 · tracked via the Priya Life Science China tracker
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd
Phase
Phase 1
Started
2026-09
Last updated
2026-09-14

Condition(s) studied

Neovascular Age-related Macular Degeneration (nAMD)Diabetic Macular Edema (DME)Retinal Vein Occlusion (RVO)

Investigational drug(s) / intervention(s)

GenSci148 Injection

GenSci148 Injection: GenSci148 is a fusion protein that simultaneously targets VEGF-A, VEGF-C, VEGF-D, and Ang-2.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Incidence and severity of treatment-emergent adverse events (TEAEs) — 43 days(Part 1) and 40 weeks (Part 2)
    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.

Trial sites (1)

FacilityCityRegionStatus
Shanghai General Hospital Shanghai Shanghai Municipality

More Changchun GeneScience Pharmaceutical Co., Ltd. trials in China

A Study on Bioequivalence of Cabergoline Tablets in Human Body Active, not recruiting
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of GenSci161 in Healthy Adult Participants Recruiting
Real-World Study on Nano-Crystalline Megestrol Acetate for Cachexia in TKI-Treated Advanced Digestive Tumors Recruiting
A Clinical Study of GenSci134 in Healthy Adults and Adult Growth Hormone Deficiency(AGHD) Recruiting
A Study (Phase 1b/2) of GS3-007a Oral Treatment in Children With Growth Hormone Deficiency (PGHD) Recruiting

Other trials for the same condition

Efficacy Evaluation Study of BAT5906 and Lucentis® in Patients With Diabetic Macular Edema Recruiting
Real-world Study of Aflibercept 8 mg in nAMD Recruiting
A Study to Determine the Efficacy, Safety, and Durability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration Active, not recruiting
Zhuochuming®-3T&E-DME Study (Treatment-naïve Patients) Starting soon
Early Combined Use of Dexamethasone Intravitreal Implant and Anti-VEGF in the Treatment of DME. Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07817615 on ClinicalTrials.gov ↗ ← All trials in China