Health TrialsbyHealthPanel

A Phase II Trial of G01 Eye Drops for Glaucomatous Optic Neuropathy

ConditionsPrimary Open-Angle GlaucomaOptic Nerve Injury
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • G01 Eye Drops 100μg/ml

    Drug

    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/ml

    Drug

    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 Drops

    Drug

    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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: G01 Eye DropsExperimental treatment 2 interventions
Group B: Placebo of G01 Eye DropsPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

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)
2

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)
3

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)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qingdao WanMing BioCell Pharmaceutics Co.,Ltd.

Lead sponsor

Source ClinicalTrials.gov
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