GVB-2001 Gene Therapy Via Intracameral Injection for the Treatment of Primary Open Angle Glaucoma (NCT06921317) | Clinical Trial Compass
RecruitingPhase 1/2
GVB-2001 Gene Therapy Via Intracameral Injection for the Treatment of Primary Open Angle Glaucoma
China6 participantsStarted 2025-11-19
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
✓. To comply with the requirements, willing to accept all the diagnosis and treatment plan, laboratory tests and other specified testing, etc.;
✓. Consent is obtained for an extended safety visit after 1 year.
✓. no vision in the target eye;
✓. The intraocular pressure (IOP) of the target eye was ≤50mmHg and \> 21 mmHg after combined treatment with 2 or more IOP-lowering drugs.
Exclusion criteria
✕. Secondary glaucoma;
What they're measuring
1
The number and proportion of subjects with IOP ≤21mmHg
Timeframe: Day 28, Day 60, Day 90, 6-Month, and 12-Month after GVB-2001 administration.
2
The number and proportion of subjects whose IOP decreased by ≥20% from baseline
Timeframe: Day 28, Day 60, Day 90, 6-Month, and 12-Month after GVB-2001 administration.
3
Ocular adverse events (AEs) : the characteristics of AES, including endophthalmitis, eyelid edema, and corneal injection site reaction
Timeframe: Day 1, Day 3, Day 7, Day 14, Day 28, Day 60, Day 90, 6-Month and 12--Month after GVB-2001 administration.