Actively Recruiting
GVB-2001 Gene Therapy Via Intracameral Injection for the Treatment of Primary Open Angle Glaucoma
Led by IVIEW Therapeutics Inc. · Updated on 2026-05-04
6
Participants Needed
1
Research Sites
118 weeks
Total Duration
On this page
Sponsors
I
IVIEW Therapeutics Inc.
Lead Sponsor
T
The First Affiliated Hospital of Soochow University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
GVB-2001 Gene Therapy Via Intracameral Injection for the Treatment of Primary Open Angle Glaucoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteers aged 18 to 75 years who have signed informed consent
- Diagnosed with primary open-angle glaucoma for one year or more
- In good general health with no significant systemic disease
- Willing to comply with study procedures, tests, and treatment plans
- Agree to attend an extended safety visit one year after treatment
- For trial group 1: no vision in the target eye and intraocular pressure between 21 and 50 mmHg despite treatment with two or more IOP-lowering drugs
- For trial group 2: intraocular pressure more than 21 mmHg and no more than 40 mmHg after treatment with two or more IOP-lowering drugs
- For trial group 2: Shaffer gonioscopy scores greater than 3 in the target eye
- For trial group 2: best corrected distance visual acuity of at least 0.3 (logMAR4.5) or better in the target eye
You will not qualify if you...
- Having secondary glaucoma
- Active or recurrent eye infection or inflammation, including uveitis
- Severe dry eye or significant active keratopathy in the target eye
- No intraocular pressure measurement available
- Allergies to drugs or excipients used in the study
- Eye trauma within 6 months or eye surgery/laser treatment within 3 months before screening
- History of herpes simplex or herpes zoster keratitis
- Positive tests for hepatitis B, hepatitis C, Epstein-Barr virus, or cytomegalovirus
- Positive syphilis or HIV antibody tests
- Severe active systemic infections
- History of malignancy, myeloproliferative disorders, or immunodeficiency
- Serious systemic diseases that could affect study results, such as uncontrolled hypertension, heart conditions, renal insufficiency, uncontrolled endocrine disorders, severe pulmonary hypertension, COPD, or interstitial pneumonia
- Serious mental illness
- Participation in other clinical trials with medication or device interventions within 1 month before screening
- Women who are pregnant, breastfeeding, planning pregnancy, or not using acceptable birth control (except those sterilized or postmenopausal)
- Other conditions judged by investigators to prevent participation
- For trial group 1: serum Anti-AAV2 neutralizing antibody titer greater than 1:200
- For trial group 2: retinal diseases interfering with the study, narrow or closed anterior chamber angle, central corneal thickness outside 480-620 micrometers, severe visual field impairment, prior intraocular anti-glaucoma surgery or laser, or serum Anti-AAV2 neutralizing antibody titer greater than 1:400
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Actively Recruiting
Research Team
Z
Zuliang Yao, MD
CONTACT
J
Jun Gao, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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