This audio article is from VisualFieldTest.com.
Read the full article here: https://visualfieldtest.com/en/a-glaucoma-eye-drop-designed-to-protect-the-optic-nerve-is-already-in-phase-ii-trials
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Excerpt:
A Glaucoma Eye Drop Designed to Protect the Optic Nerve Is Already in Phase II Trials
Status reviewed: September 4, 2026
Introduction
Glaucoma treatment has one major limitation: lowering intraocular pressure protects the eye indirectly, but it does not directly repair or support retinal ganglion cells. Some patients continue to lose retinal nerve fibers and visual field despite apparently acceptable pressure control.
G01 eye drops are designed to address that gap. The active ingredient is described as recombinant human nerve growth factor variant 2, or rhNGF-V2. The drug is being tested in a randomized Phase II trial in people with progressing primary open-angle glaucoma whose intraocular pressure is already controlled.
The central question is whether a protein placed on the eye’s surface can reach the retina and optic nerve in a sufficient amount to:
keep stressed retinal ganglion cells alive;
restore function to damaged but living cells;
stabilize retinal nerve fiber and ganglion-cell layers;
or, more ambitiously, regenerate damaged optic-nerve connections.
The short answer is:
> G01 is biologically plausible as a neuroprotective and possibly neuroenhancing treatment. Genuine optic-nerve regeneration is much less established. The largest unresolved problem is whether enough of the drug reaches the posterior eye after topical dosing.
The evidence is promising but uneven. Much of the strongest evidence comes from animal models and a small human case series. A previous randomized trial of conventional recombinant human nerve growth factor was safe but did not show statistically significant short-term improvement. G01 may be more potent because it is a modified molecule, but that remains unproven in humans.
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The Current Phase II G01 Trial
The study is registered as NCT07777861, titled:
> “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.”
It is being sponsored by Qingdao WanMing BioCell Pharmaceutics Co., Ltd. in China. The trial began enrolling on March 18, 2026. The registry lists an estimated 90 participants, with primary completion expected on October 1, 2027, and overall study completion on December 1, 2027. No results had been posted as of September 4, 2026. G01 trial record ()
Trial design
For the full table, please open this article on visualfieldtest.com.
The public registry lists two active concentrations and a placebo. Its summary formatting is not entirely consistent about the number of “groups,” but the intervention listing clearly describes two active dose arms plus a matched placebo arm. The precise allocation ratio is not stated in the accessible public record. G01 trial record ()
Who can enter the study?
The trial is designed for people with active, measurable glaucoma progression, not simply people with an abnormal optic nerve.
Key inclusion criteria include:
Primary open-angle glaucoma in one or both eyes.
Progression in the study eye demonstrated by Guided Progression Analysis of visual-field tests.
Visual-field mean deviation between −3 and −16 decibels.
Best-corrected visual acuity of at least 0.3 in decimal notation.
Intraocular pressure between 10 and 21 millimeters of mercury, with pressure considered stable by the investigator.
Ability to attend visits, follow the protocol, and provide informed consent.
Agreement to use effective contraception when applicable.
The mean-deviation range is important. A value closer to zero represents better visual-field function. A value of −16 decibels represents substantially more damage than −3 decibels. However, the trial excludes many patients with end-stage glaucoma, especially those with mean deviation worse than −16 decibels or only a small central island of remaining vision. G01 trial record ()
Major exclusion criteria
The public protocol excludes patients with:
Angle-closure, secondary, or inflammatory forms of glaucoma.
Ocular hypertension without established glaucoma.
Active or recently active herpes keratitis.
Significant infection, uveitis, keratitis, endophthalmitis, or other ocular inflammation.
Retinal disease, pathological myopia, diabetic retinopathy, retinal vascular occlusion, retinal detachment, retinitis pigmentosa, or another optic neuropathy that could affect the measurements.
Severe macular or optic-nerve disease unrelated to glaucoma.
Monocular status.
Recent corneal surgery, intraocular surgery, ocular trauma, laser trabeculoplasty, or glaucoma-filtering surgery.
Conditions that make intraocular-pressure measurement unreliable.
Known allergy to the study drug or placebo.
Recent or ongoing treatment with other potentially neuroprotective agents, including brimonidine, citicoline, nicotinamide, coenzyme Q, ginkgo biloba extract, mecobalamin, other nerve growth factor products, and certain biological preparations.
Systemic corticosteroids or other immunosuppressive medications.
Poorly controlled diabetes, severe cardiovascular disease, severe liver or kidney disease, or significant blood disorders.
Active malignancy or ongoing chemotherapy.
Pregnancy or breastfeeding.
Heavy cigarette or alcohol use, recent drug dependence, or participation in another clinical trial.
These exclusions make scientific sense because they reduce competing causes of visual-field change. However, they also mean the study will not tell us whether G01 works in combination with nicotinamide, brimonidine, citicoline, or other neuroprotective therapies. G01 trial record ()
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What the Trial Will Measure
Primary endpoint: visual-field mean deviation
The primary endpoint is the change from baseline in visual-field mean deviation at Day 168, corresponding to approximately 24 weeks of treatment.
Mean deviation is a summary score from automated visual-field testing. A worsening score generally indicates loss of visual sensitivity. An improvement would suggest that the patient detects dimmer test lights than at baseline.
However, mean deviation is not a perfect measurement of retinal ganglion-cell health. It is influenced by:
patient attention;
fatigue;
learning effects;
cataract or ocular-surface disease;
refractive correction;
test reliability;
day-to-day biological variability.
A single positive mean-deviation result would therefore be insufficient to prove neural recovery.
Secondary visual-field assessments
Visual-field mean deviation is also measured at:
Day 28;
Day 84;
Day 252;
Day 336.
The later measurements are particularly valuable because the treatment period ends at approximately Day 168. If a benefit remains at Days 252 and 336, that would support a persistent biological effect rather than a short-lived testing artifact.
The trial does not appear to use a conventional long-term visual-field slope as its primary endpoint. That is a limitation. A 24-week period is short for proving that glaucoma progression has slowed, particularly when visual-field tests are noisy.
Retinal nerve fiber layer thickness
The trial measures retinal nerve fiber layer thickness by optical coherence tomography at Days 28, 84, 168, 252, and 336.
The retinal nerve fiber layer contains the axons of retinal ganglion cells as they converge toward the optic nerve. A successful neuroprotective drug might cause:
slower thinning;
stabilization of thickness;
or, less likely, measurable thickening if some axons or supporting structures recover.
A major caution is that dead retinal ganglion-cell axons cannot normally be restored simply by keeping the remaining cells healthy. Therefore, the most realistic structural result would be less thinning, not a large increase in retinal nerve fiber layer thickness.
Macular ganglion-cell inner plexiform layer
The trial also measures the macular ganglion-cell inner plexiform layer.
This layer is often useful because it captures the cell bodies and dendritic structures of retinal ganglion cells in the central retina. It may be more sensitive than peripapillary retinal nerve fiber layer measurements in some stages of glaucoma.
Again, an apparent increase could have several explanations:
genuine recovery of stressed cells;
changes in dendritic structure;
altered tissue hydration;
segmentation error;
measurement noise.
A convincing result would require reproducible, dose-related preservation across multiple scans and preferably agreement with visual-field and visual-evoked-potential findings.
Pattern visual-evoked potential
The trial measures the P100 wave amplitude and latency of the pattern visual-evoked potential.
This test records electrical responses from the visual system after a patterned image is shown. In general:
higher P100 amplitude can indicate stronger visual pathway responses;
shorter P100 latency can indicate faster conduction.
The test is potentially valuable because it examines function along the visual pathway rather than only the retina. However, it is affected by visual acuity, attention, refractive error, electrode placement, and technical factors.
A genuine recovery signal would ideally involve:
improved or preserved mean deviation;
increased or stabilized P100 amplitude;
reduced or stabilized P100 latency;
no meaningful intraocular-pressure dif
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