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

NCT07817615 | Not Yet Recruiting Phase 1

• 1 other identifier: GenSci148-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

GenSci148; Diabetic Macular Edema; DME; Retinal Vein Occlusion; RVO; Intravitreal injection; Anti-VEGF; Angiopoietin-2; Neovascular Age-related Macular Degeneration; nAMD

Outcome Measures

Primary Outcomes (1)

• 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.

  43 days(Part 1) and 40 weeks (Part 2)

Study Arms (1)

GenSci148 Intravitreal Injection

EXPERIMENTAL

Participants receive intravitreal injections of GenSci148 at escalating dose levels. Part 1: single ascending dose (1 mg, 3 mg, 7 mg, 10 mg per eye). Part 2: multiple ascending doses in nAMD, DME, and RVO participants.

Drug: GenSci148 Injection

Interventions

GenSci148 Injection DRUG

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

GenSci148 Intravitreal Injection

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

MeSH Terms

Conditions

Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Gaohui Zhou

CONTACT

+86-021-64320070; zhougaohui@genscigroup.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study. No masking is applied. Participants, investigators, and study staff are aware of the treatment assignment.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-arm, open-label, dose-escalation study. Part 1 (SAD) evaluates 4 dose levels of single IVT injection of GenSci148 in nAMD participants. Part 2 (MAD) evaluates 3 dose levels of multiple IVT injections in nAMD, DME, and RVO participants. Dose escalation is determined by SRC based on safety and tolerability.

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 14, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)