A Phase 2 interventional study of G01 Eye Drops 100μg/ml and G01 Eye Drops 200μg/ml in Primary Open-Angle Glaucoma and Optic Nerve Injury, sponsored by Qingdao WanMing BioCell Pharmaceutics Co.,Ltd.. Recruiting at 9 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Qingdao WanMing BioCell Pharmaceutics Co.,Ltd. · Phase 2, Interventional, and Treatment
This is a randomized, double-masked, placebo-controlled Phase II clinical trial. The primary objective is to explore the efficacy of G01 Eye Drops in the treatment of optic nerve injury associated with open-angle glaucoma, providing supportive evidence for the design of subsequent clinical trials. The secondary objectives are to evaluate the safety, pharmacokinetic profiles, and immunogenicity of G01 Eye Drops in the target patient population.
Eligible patients with open-angle glaucoma and concomitant optic nerve injury will be randomized to receive either topical G01 Eye Drops or matched placebo. Multiple assessments of efficacy, safety, pharmacokinetics (PK), and immunogenicity are conducted at predefined time points following the first administration of the study drug.
The primary efficacy endpoint is the change from baseline in visual field mean deviation (MD) at Day 168. Secondary efficacy endpoints include changes from baseline in visual field MD at Days 28, 84, 252, and 336, as well as changes from baseline in retinal nerve fiber layer (RNFL) thickness, macular ganglion cell-inner plexiform layer (GCIPL) thickness, and P100 wave amplitude and latency of pattern visual evoked potential (PVEP) at Days 28, 84, 168, 252, and 336.
Additional secondary endpoints encompass pharmacokinetic characterization through plasma and tear drug concentration measurements, evaluation of anti-drug antibody (ADA) positive rates and neutralizing antibody levels, and comprehensive safety assessments throughout the study, including adverse events, vital signs, physical examinations, laboratory tests, and ophthalmic evaluations. All participants will complete the scheduled assessments according to the protocol to systematically evaluate the overall clinical profile of G01 Eye Drops.
924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.
This study's planned enrollment of 90 is above the median of 80 across 692 interventional studies indexed under Glaucoma, Open-Angle.
Browse Glaucoma, Open-Angle studies →Qingdao WanMing BioCell Pharmaceutics Co.,Ltd. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects receive G01 Eye Drops topically to the study eye for 24-week treatment period. Dosing is administered according to the trial-specified regimen, followed by a follow-up observation period. Safety, tolerability and efficacy endpoints are evaluated at scheduled study visits.
Drug: G01 Eye Drops 100μg/ml · Drug: G01 Eye Drops 200μg/ml
Subjects receive visually identical matched placebo eye drops topically to the study eye for 24-week treatment period with the identical dosing schedule as the investigational product, followed by a follow-up observation period. Safety, tolerability and efficacy endpoints are evaluated at scheduled study visits.
Drug: Placebo of G01 Eye Drops
Investigational G01 Eye Drops (100 μg/mL), administered topically to the eye, twice daily, one drop (approximately 33 μL) per dose, for a 24-week treatment period, for patients with optic nerve injury associated with primary open-angle glaucoma.
Investigational G01 Eye Drops (200 μg/mL), administered topically to the eye, twice daily, one drop (approximately 33 μL) per dose, for a 24-week treatment period, for patients with optic nerve injury associated with primary open-angle glaucoma.
Matched placebo eye drops, identical in appearance, viscosity and packaging to G01 Eye Drops. Administered topically to the eye, twice daily, one drop (approximately 33 μL) per dose for a 24-week treatment period to maintain study blinding.
Change from Baseline in Mean Deviation (MD) of Visual Field
Change from baseline in visual field mean deviation (MD) of target eye, assessed by perimetry.
Time frame: Day 168 after first study drug administration (Day 1)
Change from Baseline in Visual Field Mean Deviation (MD)
Change from baseline in visual field mean deviation (MD) of target eye at multiple post-treatment time points.
Time frame: Day 28, Day 84, Day 252, Day 336 after first study drug administration (Day 1)
Change from Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness
Change from baseline in retinal nerve fiber layer (RNFL) thickness measured by optical coherence tomography (OCT) in target eye.
Time frame: Day 28, Day 84, Day 168, Day 252, Day 336 after first study drug administration (Day 1)
Change from Baseline in Macular GCIPL Thickness
Change from baseline in macular ganglion cell-inner plexiform layer (GCIPL) thickness measured by OCT in target eye.
Time frame: Day 28, Day 84, Day 168, Day 252, Day 336 after first study drug administration (Day 1)
Change from Baseline in PVEP P100 Amplitude and Latency
Change from baseline in P100-wave amplitude and latency of pattern visual evoked potential (PVEP) for target eye.
Time frame: Day 28, Day 84, Day 168, Day 252, Day 336 after first study drug administration (Day 1)
Number of Participants With Adverse Events
The number and percentage of participants with adverse events will be summarized by treatment group. Adverse events will be evaluated for seriousness, severity, relationship to study drug, action taken, outcome, and classification as treatment-emergent adverse events (TEAEs).
Time frame: From informed consent through post-study visit, assessed up to 48 weeks after the first study drug administration
Number of Participants With Clinically Significant Abnormalities in Safety Assessments
Safety assessments include vital signs, physical examinations, 12-lead electrocardiograms, clinical laboratory tests, ocular symptom assessments, and ophthalmic examinations. The number and percentage of participants with clinically significant abnormalities will be summarized by treatment group.
Time frame: From baseline through post-study visit, assessed up to 48 weeks after the first study drug administration
Plan to share: No
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Qingdao WanMing BioCell Pharmaceutics Co.,Ltd.