GVB-2001 Gene Therapy Via Intracameral Injection for the Treatment of Primary Open Angle Glaucoma
Status:
RECRUITING
Trial end date:
2027-02-28
Target enrollment:
Participant gender:
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 12 primary open angle glaucoma (POAG) patients with high intraocular pressure (IOP) will be divided into two experimental groups. Each experimental group will receive either a low dose or a high dose interacameral injection of GVB-2001. 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 65 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.
Phase:
PHASE1
Details
Lead Sponsor:
IVIEW Therapeutics Inc.
Collaborator:
The First Affiliated Hospital of Soochow University