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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
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.
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGPeking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGPeking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGZhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGJoint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong
Shantou, Guangdong, China
RECRUITINGXiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGTianjin Eye Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGThe Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGEye Hospital, Wenzhou Medical University
Wenzhou, Zhejiang, China
RECRUITINGChange 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
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