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New treatment option for Primary Open-Angle Glaucoma (POAG)
Official title GVB-2001 Gene Therapy Via Intracameral Injection for the Treatment of Primary Open Angle Glaucoma
ClinicalTrials.gov ID: NCT06921317
What this study is testing
What is GVB-2001-high dose?
GVB-2001-high dose is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for primary open-angle glaucoma (poag).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- The people 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...
- To comply with the requirements, willing to accept all the diagnosis and treatment plan, laboratory tests and other specified testing, etc.;
You likely can't join if
- 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;
See the full eligibility criteria
- The people 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. 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 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.
- 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;
- 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...
- 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...
- Other people 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.