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RECRUITING
NCT06921317
PHASE1/PHASE2

GVB-2001 Gene Therapy Via Intracameral Injection for the Treatment of Primary Open Angle Glaucoma

Sponsor: IVIEW Therapeutics Inc.

View on ClinicalTrials.gov

Summary

This is an investigator initiated, single center, open label, non-randomized, exploratory clinical study. The purpose is to assess the safety and preliminary efficacy of gene therapy GVB-2001 (ScAAV2-dnRhoA) delivered via intracameral injection to the anterior segment of the eye for the treatment of subjects with primary open-angle glaucoma. At least 6 primary open angle glaucoma (POAG) patients with high intraocular pressure (IOP) will be divided into two experimental groups. The first subject was given low-dose treatment, and the follow-up subjects were determined by the Safety Review Committee (SRC). Each experimental group was given low-dose and high-dose drug treatment respectively, and low-dose or high-dose treatment was given. The optimal dose will be selected based on the trial results for future development of GVB-2001. Safety Review Committee, SRC will be set up for safety assessment of the study. The study subjects included will be 18 to 75 years of age (inclusion) and are diagnosed with primary open-angle glaucoma (POAG) for 1 year or more. Only participants who provide informed consent prior to all screening procedures will be eligible for enrollment into the trial.

Official title: Proof of Concept Clinical Trial of Gene Therapy GVB-2001 Delivered Via Intracameral Injection for the Treatment of Primary Open Angle Glaucoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2025-11-19

Completion Date

2028-02-28

Last Updated

2026-05-04

Healthy Volunteers

No

Interventions

DRUG

GVB-2001-high dose

GVB-2001 is a self-complementary adeno-associated viral vector (scAAV) injection to deliver human dnRhoA gene to trabecular meshwork cells in patients with primary open angle glaucoma. A single dose of high dose GVB-2001 will be injected intracamerally to the target interventional eye.

DRUG

GVB-2001-low dose

GVB-2001 is a self-complementary adeno-associated viral vector (scAAV) injection to deliver human dnRhoA gene to trabecular meshwork cells in patients with primary open angle glaucoma. A single dose of low dose GVB-2001 will be injected intracamerally to the target interventional eye.

Locations (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China