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.
The subjects volunteered to participate in the clinical study and signed written informed consent;
Aged 18 to 75 years old (inclusive), men and women;
Primary open angle glaucoma (POAG) with a history of diagnosis ≥1 year;
Participants in good general health and have no clinically significant systemic disease, as determined by medical history, physical examination, and screening laboratory evaluation.
Secondary glaucoma;
Any active or recurrent intraocular infection or inflammation, including but not limited to uveitis;
Severe dry eye or clinically significant active keratopathy in the target eye;
No intraocular pressure measurement was performed under any circumstances;
IVIEW Therapeutics Inc.
Lead sponsor
The First Affiliated Hospital of Soochow University
Collaborator