Primary Open-Angle GlaucomaPhase 2NCT07777861
A Phase II Trial of G01 Eye Drops for Glaucomatous Optic Neuropathy
A Phase 2 study testing G01 Eye Drops 100μg/ml and G01 Eye Drops 200μg/ml in people with Primary Open-Angle Glaucoma and Optic Nerve Injury, run by Qingdao WanMing BioCell Pharmaceutics Co.,Ltd. at 9 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Open-Angle Glaucoma, Optic Nerve Injury
- What is being tested?
- G01 Eye Drops 100μg/ml and G01 Eye Drops 200μg/ml
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 9 sitesChina
- Study dates
- 18 Mar 2026to 1 Dec 2027
- Phase
- Phase 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 28Show fewer
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong
- Recruiting
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
- Recruiting
Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong
Shantou, Guangdong
- Recruiting
Tianjin Eye Hospital
Tianjin, Tianjin Municipality
- Recruiting
Eye Hospital, Wenzhou Medical University
Wenzhou, Zhejiang, 325027
About this study
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
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.
Read the detailed description
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.
- Conditions
- Primary Open-Angle Glaucoma, Optic Nerve Injury
- Being tested
- G01 Eye Drops 100μg/ml, G01 Eye Drops 200μg/ml, Placebo of G01 Eye Drops
- Medical subject headings
- Glaucoma, Open-Angle, Optic Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G01 Eye Drops 100μg/mlDrug
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.
G01 Eye Drops 200μg/mlDrug
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.
Placebo of G01 Eye DropsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| G01 Eye Drops | Experimental | 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. Receives: Drug: G01 Eye Drops 100μg/ml; Drug: G01 Eye Drops 200μg/ml |
| Placebo of G01 Eye Drops | Placebo comparator | 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. Receives: Drug: Placebo of G01 Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 168 after first study drug administration (Day 1)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: From baseline through post-study visit, assessed up to 48 weeks after the first study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start18 Mar 2026
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Primary Open-Angle GlaucomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingdao WanMing BioCell Pharmaceutics Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuanbo Liang, Principal investigator, Eye Hospital, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777861
- Sponsor's protocol ID
- WM-G01-OAGII
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beykin G, Stell L, Halim MS, Nunez M, Popova L, Nguyen BT, Groth SL, Dennis A, Li Z, Atkins M, Khavari T, Wang SY, Chang R, Fisher AC, Sepah YJ, Goldberg JL. Phase 1b Randomized Controlled Study of Short Course Topical Recombinant Human Nerve Growth Factor (rhNGF) for Neuroenhancement in Glaucoma: Safety, Tolerability, and Efficacy Measure Outcomes. Am J Ophthalmol. 2022 Feb;234:223-234. doi: 10.1016/j.ajo.2021.11.002. Epub 2021 Nov 13.
PubMed 34780798Lambiase A, Aloe L, Centofanti M, Parisi V, Bao SN, Mantelli F, Colafrancesco V, Manni GL, Bucci MG, Bonini S, Levi-Montalcini R. Experimental and clinical evidence of neuroprotection by nerve growth factor eye drops: Implications for glaucoma. Proc Natl Acad Sci U S A. 2009 Aug 11;106(32):13469-74. doi: 10.1073/pnas.0906678106.
PubMed 19805021Colafrancesco V, Parisi V, Sposato V, Rossi S, Russo MA, Coassin M, Lambiase A, Aloe L. Ocular application of nerve growth factor protects degenerating retinal ganglion cells in a rat model of glaucoma. J Glaucoma. 2011 Feb;20(2):100-8. doi: 10.1097/IJG.0b013e3181d787e5.
PubMed 20436364Guo L, Davis BM, Ravindran N, Galvao J, Kapoor N, Haamedi N, Shamsher E, Luong V, Fico E, Cordeiro MF. Topical recombinant human Nerve growth factor (rh-NGF) is neuroprotective to retinal ganglion cells by targeting secondary degeneration. Sci Rep. 2020 Feb 25;10(1):3375. doi: 10.1038/s41598-020-60427-2.
PubMed 32099056The effectiveness of intraocular pressure reduction in the treatment of normal-tension glaucoma. Collaborative Normal-Tension Glaucoma Study Group. Am J Ophthalmol. 1998 Oct;126(4):498-505. doi: 10.1016/s0002-9394(98)00272-4.
PubMed 9780094Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.
PubMed 16488940Harasymowycz P, Birt C, Gooi P, Heckler L, Hutnik C, Jinapriya D, Shuba L, Yan D, Day R. Medical Management of Glaucoma in the 21st Century from a Canadian Perspective. J Ophthalmol. 2016;2016:6509809. doi: 10.1155/2016/6509809. Epub 2016 Nov 8.
PubMed 27895937
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07777861
- Acronym / sponsor ID
- WM-G01-OAGII
- Conditions
- Primary Open-Angle Glaucoma, Optic Nerve Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Qingdao WanMing BioCell Pharmaceutics Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 20 Aug 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G01 Eye Drops | Experimental | Drug: G01 Eye Drops 100μg/ml, Drug: G01 Eye Drops 200μg/mlSubjects 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. |
| Placebo of G01 Eye Drops | Placebo comparator | Drug: Placebo of G01 Eye DropsSubjects 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (28 listed)
- 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).
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 |
|---|---|---|
| G01 Eye Drops 100μg/mlInvestigational 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. | Drug | G01 Eye Drops |
| G01 Eye Drops 200μg/mlInvestigational 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. | Drug | G01 Eye Drops |
| Placebo of G01 Eye DropsMatched 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. | Drug | Placebo of G01 Eye Drops |
Primary outcome
Change from Baseline in Mean Deviation (MD) of Visual Field
Time frame: Day 168 after first study drug administration (Day 1)
Change from baseline in visual field mean deviation (MD) of target eye, assessed by perimetry.
6 secondary outcomes
Change from Baseline in Visual Field Mean Deviation (MD)
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
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
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
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
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
Time frame: From baseline through post-study visit, assessed up to 48 weeks after the first study drug 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 24 Aug 2026.
- Background: PubMed 34780798Beykin G, Stell L, Halim MS, Nunez M, Popova L, Nguyen BT, Groth SL, Dennis A, Li Z, Atkins M, Khavari T, Wang SY, Chang R, Fisher AC, Sepah YJ, Goldberg JL. Phase 1b Randomized Controlled Study of Short Course Topical Recombinant Human Nerve Growth Factor (rhNGF) for Neuroenhancement in Glaucoma: Safety, Tolerability, and Efficacy Measure Outcomes. Am J Ophthalmol. 2022 Feb;234:223-234. doi: 10.1016/j.ajo.2021.11.002. Epub 2021 Nov 13.
- Background: PubMed 19805021Lambiase A, Aloe L, Centofanti M, Parisi V, Bao SN, Mantelli F, Colafrancesco V, Manni GL, Bucci MG, Bonini S, Levi-Montalcini R. Experimental and clinical evidence of neuroprotection by nerve growth factor eye drops: Implications for glaucoma. Proc Natl Acad Sci U S A. 2009 Aug 11;106(32):13469-74. doi: 10.1073/pnas.0906678106.
- Background: PubMed 20436364Colafrancesco V, Parisi V, Sposato V, Rossi S, Russo MA, Coassin M, Lambiase A, Aloe L. Ocular application of nerve growth factor protects degenerating retinal ganglion cells in a rat model of glaucoma. J Glaucoma. 2011 Feb;20(2):100-8. doi: 10.1097/IJG.0b013e3181d787e5.
- Background: PubMed 32099056Guo L, Davis BM, Ravindran N, Galvao J, Kapoor N, Haamedi N, Shamsher E, Luong V, Fico E, Cordeiro MF. Topical recombinant human Nerve growth factor (rh-NGF) is neuroprotective to retinal ganglion cells by targeting secondary degeneration. Sci Rep. 2020 Feb 25;10(1):3375. doi: 10.1038/s41598-020-60427-2.
- Background: PubMed 9780094The effectiveness of intraocular pressure reduction in the treatment of normal-tension glaucoma. Collaborative Normal-Tension Glaucoma Study Group. Am J Ophthalmol. 1998 Oct;126(4):498-505. doi: 10.1016/s0002-9394(98)00272-4.
- Background: PubMed 16488940Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.
- Background: PubMed 27895937Harasymowycz P, Birt C, Gooi P, Heckler L, Hutnik C, Jinapriya D, Shuba L, Yan D, Day R. Medical Management of Glaucoma in the 21st Century from a Canadian Perspective. J Ophthalmol. 2016;2016:6509809. doi: 10.1155/2016/6509809. Epub 2016 Nov 8.
- Individual participant dataSharing planned: No
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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.
Yuanbo Liang principal investigator
Eye Hospital, Wenzhou Medical University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing G01 Eye Drops 100μg/ml and G01 Eye Drops 200μg/ml in people with Primary Open-Angle Glaucoma and Optic Nerve Injury, run by Qingdao WanMing BioCell Pharmaceutics Co.,Ltd. at 9 sites 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 8 inclusion and 28 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 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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 Shixiang Lu (+86-13573851355, lushixiang@wmpharmaceutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Mean Deviation (MD) of Visual Field (time frame: Day 168 after first study drug administration (Day 1)). 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 NCT07777861, which also lists 7 linked publications.
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 24 Aug 2026.