G01 Eye Drops for Glaucomatous Optic Neuropathy
Official title: A Randomized, Double-Masked, Placebo-Controlled Phase II Clinical Trial Evaluating the Efficacy and Safety of G01 Eye Drops in the Treatment of Optic Nerve Injury Associated With Open-Angle Glaucoma
Run by Qingdao WanMing BioCell Pharmaceutics Co.,Ltd. · NCT07777861 · Data updated 2026-11-12
This trial tests whether G01 Eye Drops can help people with open-angle glaucoma who also have optic nerve injury.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Qingdao WanMing BioCell Pharmaceutics Co.,Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 9 sites (Beijing, Beijing Municipality and 8 other locations) |
| Status | Recruiting |
| Started | March 18, 2026 |
| Main results expected | October 1, 2027 |
| Study ends | December 1, 2027 |
| Registry record updated | August 24, 2026 |
| Trial ID | NCT07777861 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–80 with primary open-angle glaucoma and documented optic nerve injury showing progression, acceptable baseline vision, and controlled intraocular pressure.
✕Probably not a fit
Patients without optic nerve injury, with non-progression, or those not meeting risk/therapy criteria may not experience benefit from this treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, double-masked, placebo-controlled Phase II trial evaluating the safety and efficacy of G01 Eye Drops in adults with primary open-angle glaucoma and optic nerve injury. Participants receive either G01 Eye Drops at 100 or 200 μg/mL or a matched placebo, with multiple efficacy, PK, and immunogenicity assessments over a 336-day period. Primary efficacy is the change in visual field mean deviation from baseline at Day 168; secondary endpoints include RNFL and GCIPL thickness, PVEP metrics, and PK/ADA safety measures. The study also monitors adverse events, vital signs, labs, and eye examinations to establish a comprehensive clinical profile. Eligible adults aged 18–80 with POAG, progressive disease, and controlled intraocular pressure may participate across multiple Beijing-based sites.
Why it matters
Potential benefit: If successful, G01 Eye Drops could slow vision loss and improve or stabilize visual function in patients with POAG and optic nerve injury.
How similar studies have gone: Previous studies of similar topical therapies in glaucoma have shown variable efficacy, making this approach exploratory but with potential for meaningful signals.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age from 18 to 80 years (inclusive) at the time of signing the informed consent form, regardless of gender. * Diagnosis of primary open-angle glaucoma (POAG) in one or both eyes. * Goal eye demonstrates disease progression as shown by Guided Progression Analysis (GPA) visual field testing at screening. * Mean Deviation (MD) of the visual field in the goal eye ≥-16 dB and ≤-3 dB. * Best-corrected visual acuity of the goal eye ≥0.3; spherical equivalent refraction ≥-8 D (spherical equivalent = spherical refraction + 1/2 cylindrical refraction) OR axial length ≤28 mm in the goal eye. * Intraocular pressure of the goal eye ranges from 10 mmHg to 21 mmHg (inclusive) under hypotensive medication, post-glaucoma surgery, or no medication; and the intraocular pressure is judged stably controlled by the investigator. * Subjects and their partners agree to use effective physical and/or pharmacological contraception from screening through 3 months after study completion; no plan for sperm/egg donation or pregnancy. * Voluntarily sign the informed consent form for participation in this clinical trial and comply with investigator-provided instructions. Exclusion Criteria: * Goal eye diagnosed as angle-closure glaucoma, glaucomatocyclitic crisis, ocular hypertension, or secondary glaucoma. * Active herpetic keratitis in the goal eye within 1 year prior to screening, or receiving antiviral therapy at screening. * Active or recurrent ocular infection in either eye that may interfere with trial evaluations (e.g., iridocyclitis, conjunctivitis, keratitis, uveitis, endophthalmitis). * Disease in either eye preventing adequate examination of the fundus or anterior segment. * Fundus disorders in the goal eye that may cause severe visual loss or interfere with efficacy/safety assessments (e.g., pathological myopia, diabetic retinopathy, central retinal vein/artery occlusion, retinal detachment, retinitis pigmentosa, non-glaucomatous optic neuropathy, choroidal melanoma, hematological or vascular diseases). * Monocular subjects. * Ocular infection or corneal-iris-lens lesions in the goal eye judged by the investigator to interfere with efficacy or safety evaluations of the study. * Corneal surgery on the goal eye within 3 months before screening (e.g., PRK, LASIK, SMILE, corneal cross-linking, radial keratotomy); or other conditions affecting intraocular pressure measurement (e.g., corneal edema, corneal scar, keratoconus). * History of retinal laser surgery covering the macular region in the goal eye. * Intraocular surgery on the goal eye (e.g., cataract surgery, fundus surgery) or ocular trauma within 3 months before screening; or planned ocular surgery during the study period. * Glaucoma laser therapy (e.g., laser trabeculoplasty) performed on the goal eye within 1 year prior to screening. * Filtering surgery for glaucoma on the goal eye within 1 year prior to screening (e.g., trabeculectomy, non-penetrating trabeculectomy, glaucoma drainage device implantation, cyclophotocoagulation). * Known or suspected allergy to any component of the study drug or placebo. * Initiation of neurotrophic medications within 28 days before screening or anticipated during the trial (e.g., nerve growth factor other than study drug, brimonidine eye drops, coenzyme Q, ginkgo biloba extract, citicoline, nicotinamide, mecobalamin, autologous serum eye drops, deproteinized calf blood extract-related preparations). * Discontinuation period of prior growth-factor-based therapy does not exceed 5 half-lives AND/OR 14 days (the longer of 5 half-lives and 14 days shall be applied). * Unwilling or unable to discontinue contact lens wear (including cosmetic contact lenses) throughout the study. * Receiving systemic corticosteroids or other immunosuppressive agents. * Poorly-controlled hypertension: systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg despite pharmacological treatment. * Severe cardiovascular, hepatic, renal, or hematological disorders; poorly-controlled diabetes (random blood glucose \>11.1 mmol/L at screening, HbA1c \>8%, or insulin-dependent glycemic control). * Positive for HBeAg, HCV-Ab, HIV antibody, or TP-Ab. * Unable to complete trial procedures due to severe psychiatric or language barriers. * Participation in another clinical trial within 30 days prior to screening. * Cigarette consumption \>10 cigarettes per day within 3 months before screening, or alcohol intake \>14 alcohol units per week (1 unit =10 mL ethanol =200 mL 5%-ABV beer =25 mL 40%-ABV spirits =83 mL 12%-ABV wine). * History of malignancy (excluding basal cell carcinoma), unless treatment was completed at least 2 years prior to screening. * Ongoing chemotherapy. * History of drug dependence, drug abuse, or illicit-drug use within 5 years prior to screening. * Female subjects who are pregnant, lactating, or with positive serum pregnancy test. * Subjects deemed unsuitable for participation by the investigator.
Where it's running
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Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China Recruiting -
Peking University First Hospital
Beijing, Beijing Municipality, China Recruiting -
Peking University Third Hospital
Beijing, Beijing Municipality, China Recruiting -
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China Recruiting -
Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong
Shantou, Guangdong, China Recruiting -
Xiangya Hospital of Central South University
Changsha, Hunan, China Recruiting
Show 3 more locations
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Tianjin Eye Hospital
Tianjin, Tianjin Municipality, China Recruiting -
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China Recruiting -
Eye Hospital, Wenzhou Medical University
Wenzhou, Zhejiang, China Recruiting
Study contacts
- Principal investigator: Yuanbo Liang — Eye Hospital, Wenzhou Medical University
- Study coordinator: Shixiang Lu
- Email: lushixiang@wmpharmaceutics.com
- Phone: +86-13573851355
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.