A Phase II Trial of G01 Eye Drops for Glaucomatous Optic Neuropathy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorQingdao WanMing BioCell Pharmaceutics Co.,Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- G01 Eye Drops 100μg/ml
- G01 Eye Drops 200μg/ml
- Placebo of G01 Eye Drops
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov