RecruitingPhase 1Phase 2NCT06921317

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

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

Sponsor

IVIEW Therapeutics Inc.

Enrollment

6 participants

Start Date

Nov 19, 2025

Study Type

INTERVENTIONAL

Conditions

Primary Open Angle Glaucoma (POAG)

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new gene therapy called GVB-2001, injected directly into the eye, as a treatment for primary open-angle glaucoma — the most common form of glaucoma, caused by gradual damage to the optic nerve from elevated eye pressure. The therapy aims to lower eye pressure long-term. **You may be eligible if...** - You are between 18 and 70 years old - You have had primary open-angle glaucoma for at least 1 year - You are in generally good health - For the first treatment group: the target eye has no remaining vision and eye pressure is within a specific range **You may NOT be eligible if...** - You have other types of glaucoma (not open-angle) - You have had certain eye surgeries or serious eye conditions - You have uncontrolled systemic diseases that may affect the study - You are under 18 or over 70 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGVB-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.

DRUGGVB-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.