Primary Open-Angle Glaucoma (POAG)Phase 1/2NCT06921317

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

A Phase 1/2 study testing GVB-2001-high dose and GVB-2001-low dose in people with Primary Open-Angle Glaucoma (POAG), run by IVIEW Therapeutics Inc. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Primary Open-Angle Glaucoma (POAG)
What is being tested?: GVB-2001-high dose and GVB-2001-low dose
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteChina
Study dates: 19 Nov 2025to 28 Feb 2028
Phase: Phase 1/2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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Special eligibility criteria for trial group 1:
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.
Special inclusion criteria for trial group 2:
The intraocular pressure (IOP) of the target intervention eye was no more than 40mmHg, and the IOP was more than 21 mmHg after receiving combination therapy of 2 or more IOP-lowering drugs;
The Shaffer gonioscopy scores of the target intervention eyes were all greater than 3.
The best corrected distance visual acuity of the target intervention eyes was at least 0.3 (logMAR4.5) and above.

Who cannot join

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;
Allergies to drugs or their excipient to be used in clinical studies;
Ocular trauma in either eye within 6 months before screening, or eye surgery or nonrefractive laser therapy within 3 months before screening;

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A clinically significant history of herpes simplex or herpes zoster keratitis;
A positive test for hepatitis B virus (HBV) HBsAg or HBV-DNA, hepatitis C virus (HCV) HCAb, or Epstein-Barr virus, or cytomegalovirus (CMV);
Syphilis antibody and HIV antibody were positive.
Severe active systemic bacterial, viral, fungal, malaria, or parasitic infections;
Any past or present malignant tumor, myeloproliferative disorder or immunodeficiency disease;
May interfere with the clinical significance of this study of systemic disease (including, active hepatitis, liver cirrhosis, liver fibrosis uncontrolled hypertension, myocardial infarction and myocarditis, arrhythmia, stroke, acute or chronic renal insufficiency, uncontrolled endocrine system diseases such as diabetes, thyroid function hyperfunction, Severe pulmonary hypertension, chronic obstructive pulmonary disease (copd), interstitial pneumonia, etc.);
Any serious mental illness;
Have participated in other clinical trials and received a medication or medical device intervention within 1 month before screening;
And women of childbearing age who are pregnant, breastfeeding, planning to become pregnant, or who are not using a medically acceptable form of birth control. Excludes women of childbearing age who have been sterilized for 1 year after menopause or 3 months after surgery;
Other subjects judged by the clinical investigator to be ineligible for inclusion.
Special Exclusion Criteria for trial group 1:
1) The serum Anti-AAV2 neutralizing antibody titer was > 1:200 at the time of screening.
Special Exclusion Criteria for trial group 2:
Retinal diseases that might have interfering with the study: quadrantinal blindness of unknown cause, wet age-related macular degeneration, retinal vein occlusion, cystoid macular edema, macular hole, maculopathy with neovascularization, and central serous retinopathy;
Narrow anterior chamber Angle, congenital Angle closure glaucoma or room, clinically significant peripheral anterior chamber adhesion or anterior chamber Angle surgery/laser treatment cause extensive catarrhal adhesion of history;
The central corneal thickness was less than 480μm or more than 620μm.
Presence of severe visual field impairment (e.g., mean deviation less than -12 dB or mean visual field defect greater than 2 dB/ year, as assessed by a perimetry analyzer)
The target eye had undergone intraocular anti-glaucoma surgery or anti- glaucoma laser surgery;
The serum Anti-AAV2 neutralizing antibody titer was > 1:400 at the time of screening.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zuliang Yao, MD contact

+1 609 773 8580

zuliang.yao@iviewinc.com

Jun Gao, MD contact

jun.gao@iviewinc.com

China1 site, 1 recruiting

The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Peirong Lu, MD, +86 512 67972743, lupeirong@suda.edu.cn
Qiang Hu, qiang.hu@iviewinc.com
Recruiting

Other trials in China

About this study

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

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.

Read the detailed description

This research plans to recruit at least 6 high intraocular pressure of primary open-angle glaucoma (POAG) patients in one clinical center and divide into two groups. Three primary glaucoma (POAG) patients with elevated intraocular pressure and no vision in the target eye will be enrolled in trial group 1. They will be divided into two dose groups: low-dose group (n = 1) and high-dose group (n = 2). The safety review committee (SRC) will determine whether to enter the high- dose group after the last subject in the low-dose group has completed the Dose limited toxicity (DLT) assessment. In group 2, 3 primary open-angle (POAG) patients with normal visual acuity and high intraocular pressure will be enrolled. The safety review committee (SRC) will determine whether to enter the low-dose group of trial group 2, and whether to enter the high-dose group of trial group 2, after the completion of the evaluation of DLT in the low-dose group of trial group 1. During the study of trial group 2, the safety review committee (SRC) will determine whether to add another optimized dose group to trial group 2, and determine the optimized therapeutic dose and the number of subjects in the optimized dose group.

Conditions: Primary Open-Angle Glaucoma (POAG)
Being tested: GVB-2001-high dose, GVB-2001-low dose
Keywords: glaucoma, gene therapy, rho gene, trabecular meshwork, dnRhoA, IOP reduction, AAV, scAAV
Medical subject headings: Glaucoma, Open-Angle, Glaucoma, Night Blindness, Congenital Stationary, Autosomal Dominant 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GVB-2001-high doseDrug
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.
GVB-2001-low doseDrug
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.

Study groups in NCT06921317
Study group	Role	What they receive
Group 1: POAG patient without vision	Experimental	Low dose or high dose GVB-2001 25ul will be injected once into the anterior chamber by the investigator at visit 2. Receives: Drug: GVB-2001-high dose; Drug: GVB-2001-low dose
Group 2: POAG patient with vision	Experimental	Low dose or high dose GVB-2001 will be injected once into the anterior chamber by the investigator at visit 2. Receives: Drug: GVB-2001-high dose; Drug: GVB-2001-low dose

What is being measured

The primary outcome is the main question the study is designed to answer.

The number and proportion of subjects with IOP ≤21mmHg
Measured: Day 28, Day 60, Day 90, 6-Month, and 12-Month after GVB-2001 administration.
The number and proportion of subjects whose IOP decreased by ≥20% from baseline
Measured: Day 28, Day 60, Day 90, 6-Month, and 12-Month after GVB-2001 administration.
Ocular adverse events (AEs) : the characteristics of AES, including endophthalmitis, eyelid edema, and corneal injection site reaction
Measured: Day 1, Day 3, Day 7, Day 14, Day 28, Day 60, Day 90, 6-Month and 12--Month after GVB-2001 administration.

Secondary outcomes (12)

Type, number, and incidence of systemic adverse events and serious adverse events
Measured: Adverse events (AEs): The type, number and incidence of AEs and serious adverse events (SAEs) will be analysized within 12 months after GVB-2001 administration.
The number of ocular malignancies related to GVB-2001 injection occurred after treatment
Measured: After GVB-2001 Administration up to 5 years.
RhoA protein concentration in blood
Measured: Day 7, Day 28, and 12-Month after GVB-2001 administration
RhoA protein concentration in urine
Measured: Day 7, Day 28, and 12-Month after GVB-2001 administration
RhoA protein concentration in tears
Measured: Day 7, Day 28, and 12-Month after GVB-2001 administration
AAV2 Virus Shedding in blood
Measured: Day 7, Day 28, and Month 12 after GVB-2001 administration
AAV2 Virus Shedding in urine
Measured: Day 7, Day 28, and 12-Month after GVB-2001 administration
AAV2 Virus Shedding in tears
Measured: Day 7, Day 28, and 12-Month after GVB-2001 administration
Humoral immunity response
Humoral immunity response is evaluated by comprehensive judgements of IgG, IgM, IgA, complements and Light chains in blood. It's applied to assess safety.
Measured: Day 7, Day 28, and 12-Month after GVB-2001 administration
Cellular immunity response
Cellular immunity response is evaluated by comprehensive judgements of CD3 CD4 CD8 in blood. It's applied to assess safety.
Measured: Day 7, Day 28, and 12-Month after GVB-2001 administration
AAV2 antibody titer level in blood
Compare antibody level to baseline. It's applied to assess safety.
Measured: Day 7, Day 28, and 12-Month after GVB-2001 administration.
Occurance of Dose limiting toxicity (DLT) as determined by the Safety Monitoring Committee (SRC)
Measured: Day 28 after GVB-2001 administration.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Nov 202528 Feb 2028

First posted10 Apr 2025
Study start19 Nov 2025
Primary completion30 Dec 2027 (estimated)
Study completion28 Feb 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Primary Open-Angle Glaucoma (POAG)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 6 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06921317
Sponsor's protocol ID: GVB-2001-GLU-IIT
Status last verified: Apr 2026
First submitted: 25 Mar 2025
Last updated: 4 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Zuliang Yao, MD

+1 609 773 8580

zuliang.yao@iviewinc.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Primary Open-Angle Glaucoma (POAG) trials

Study at a glance

From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Proof of Concept Clinical Trial of Gene Therapy GVB-2001 Delivered Via Intracameral Injection for the Treatment of Primary Open Angle Glaucoma
ClinicalTrials.gov ID: NCT06921317
Acronym / sponsor ID: GVB-2001-GLU-IIT
Conditions: Primary Open-Angle Glaucoma (POAG)
Keywords: glaucoma, gene therapy, rho gene, trabecular meshwork, dnRhoA, IOP reduction, AAV, scAAV
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 6 participants (estimated)
Lead sponsor: IVIEW Therapeutics Inc.Industry (pharma, biotech, devices)
Collaborators: The First Affiliated Hospital of Soochow University
Study start: 19 Nov 2025 (actual)
Primary completion: 30 Dec 2027 (estimated)
Study completion: 28 Feb 2028 (estimated)
First posted: 10 Apr 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1: POAG patient without vision	Experimental	Drug: GVB-2001-high dose, Drug: GVB-2001-low doseLow dose or high dose GVB-2001 25ul will be injected once into the anterior chamber by the investigator at visit 2.
Group 2: POAG patient with vision	Experimental	Drug: GVB-2001-high dose, Drug: GVB-2001-low doseLow dose or high dose GVB-2001 will be injected once into the anterior chamber by the investigator at visit 2.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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.;

Key exclusion criteria (25 listed)

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;
Allergies to drugs or their excipient to be used in clinical studies;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GVB-2001-high doseGVB-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.	Drug	Group 1: POAG patient without vision, Group 2: POAG patient with vision
GVB-2001-low doseGVB-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.	Drug	Group 1: POAG patient without vision, Group 2: POAG patient with vision

Primary outcome

The number and proportion of subjects with IOP ≤21mmHg
Time frame: Day 28, Day 60, Day 90, 6-Month, and 12-Month after GVB-2001 administration.
The number and proportion of subjects whose IOP decreased by ≥20% from baseline
Time frame: Day 28, Day 60, Day 90, 6-Month, and 12-Month after GVB-2001 administration.
Ocular adverse events (AEs) : the characteristics of AES, including endophthalmitis, eyelid edema, and corneal injection site reaction
Time frame: Day 1, Day 3, Day 7, Day 14, Day 28, Day 60, Day 90, 6-Month and 12--Month after GVB-2001 administration.

12 secondary outcomes

Type, number, and incidence of systemic adverse events and serious adverse events
Time frame: Adverse events (AEs): The type, number and incidence of AEs and serious adverse events (SAEs) will be analysized within 12 months after GVB-2001 administration.
The number of ocular malignancies related to GVB-2001 injection occurred after treatment
Time frame: After GVB-2001 Administration up to 5 years.
RhoA protein concentration in blood
Time frame: Day 7, Day 28, and 12-Month after GVB-2001 administration
RhoA protein concentration in urine
Time frame: Day 7, Day 28, and 12-Month after GVB-2001 administration
RhoA protein concentration in tears
Time frame: Day 7, Day 28, and 12-Month after GVB-2001 administration
AAV2 Virus Shedding in blood
Time frame: Day 7, Day 28, and Month 12 after GVB-2001 administration
AAV2 Virus Shedding in urine
Time frame: Day 7, Day 28, and 12-Month after GVB-2001 administration
AAV2 Virus Shedding in tears
Time frame: Day 7, Day 28, and 12-Month after GVB-2001 administration
Humoral immunity response
Time frame: Day 7, Day 28, and 12-Month after GVB-2001 administration
Cellular immunity response
Time frame: Day 7, Day 28, and 12-Month after GVB-2001 administration
AAV2 antibody titer level in blood
Time frame: Day 7, Day 28, and 12-Month after GVB-2001 administration.
Occurance of Dose limiting toxicity (DLT) as determined by the Safety Monitoring Committee (SRC)
Time frame: Day 28 after GVB-2001 administration.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
Individual participant dataSharing planned: No

Related trials for Primary Open-Angle Glaucoma (POAG)

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Zuliang Yao, MD contact

+1 609 773 8580

zuliang.yao@iviewinc.com

Jun Gao, MD contact

jun.gao@iviewinc.com

Peirong Lu, MD principal investigator

The First Affiliated Hospital of Soochow University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GVB-2001-high dose and GVB-2001-low dose in people with Primary Open-Angle Glaucoma (POAG), run by IVIEW Therapeutics Inc. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zuliang Yao, MD (+1 609 773 8580, zuliang.yao@iviewinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number and proportion of subjects with IOP ≤21mmHg (time frame: Day 28, Day 60, Day 90, 6-Month, and 12-Month after GVB-2001 administration.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06921317.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.