Tests metformin to protect the optic nerve in glaucoma
Tests metformin, a diabetes drug, against placebo in adults with glaucoma.
Key facts
- Who runs it
- Christopher Kai Shun Leung
- Where
- Wong Chuk Hang, Hong KongSee the site
- Trial code
- Registry title
- Metformin as a Neuroprotective Therapy for Glaucoma
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 125 people, planned
- Started
- 1 Jun 2025
- Expected to end
- 31 Dec 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Metformin
- Placebo
- Record updated
- 20 November 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with primary open angle glaucoma whose optic nerve layers are getting thinner over time. It tests metformin against placebo.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Glaucoma with progressive thinning of the retinal nerve fiber layer and/or ganglion cell inner plexiform layer in at least one eye over the past 3 years, shown by OCT progression analysis.
- Biomarker or test result
- Eye pressure of 24mmHg or lower at the screening and baseline visits. Best corrected visual acuity of 20/40 or better.
Main reasons for not taking part
- Diabetes, kidney disease or liver disease
- Pathological myopia
- Cognitive impairment, such as Alzheimer's disease
- Other diseases that can cause visual field loss or optic disc changes
- Cannot do a reliable visual field test, or poor quality OCT images
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- age ≥18 years
- best corrected VA ≥20/40
- IOP ≤24mmHg at the screening and baseline visits
- progressive RNFL and/or GCIPL thinning by TPA or GPA over the past 3 years in at least one eye
Who cannot take part
- patients with DM, kidney or liver diseases
- cognitive impairment (e.g. Alzheimer's disease)
- diseases that may cause visual field loss or optic disc abnormalities other than glaucoma
- pathological myopia
- inability to perform reliable visual field
- suboptimal quality of OCT images; Both eyes of a patient will be included in the analysis if both eyesare eligible for inclusion
Where in Hong Kong
- HKU Eye CentreWong Chuk Hang, Hong KongContact: Gilda LAITaking people
About the trial
What the trial wants to find out
Glaucoma, a chronic degenerative disease of the optic nerve, is the leading cause of irreversible blindness worldwide. Although lowering the intraocular pressure (IOP) has been shown to be effective to slow optic nerve degeneration, a significant portion of glaucoma patients continue to develop progressive loss in vision despite adequate control of IOP. Development of neuroprotective therapy to prevent optic nerve degeneration by mechanisms other than IOP- lowering is critical to reduce the burden of glaucoma blindness. With 76 million glaucoma patients in 2020 worldwide, the need to investigate neuroprotection for glaucoma is pressing. While metformin is a widely adopted oral hypoglycemic medication for treatment of type 2 diabetes mellitus (DM), increasing evidence from clinical studies has shown that metformin can decrease the risk of many age-related diseases including neurodegenerative diseases. In a retrospective study of 150,016 patients with DM, those taking metformin at >1500mg/day had a 25% reduced risk of development of open-angle glaucoma than those who took no metformin. Metformin has a high safety profile. The investigators aim to investigate whether metformin can be repurposed to a neuroprotective therapy for glaucoma patients in a randomized controlled trial.
Read full original descriptionShow less
The investigators propose to conduct a 24-month, double-blind, placebo-controlled, parallel group, randomizing 125 primary open angle glaucoma patients who have progressive retinal nerve fiber layer (RNFL) and/or ganglion cell inner plexiform layer (GCIPL) thinning in at least one eye, as determined by optical coherence tomography Trend-based Progression Analysis (TPA) or Guided Progression Analysis (GPA), to receive metformin 1500mg/day or placebo. All patients will be followed up at 2-month intervals for IOP, RNFL thickness, and visual field (VF) measurements. The objectives are to compare (1) the rates of change of average RNFL thickness (primary outcome measure), and (2) the rates of change of VF mean deviation (MD) (secondary outcome measure) between treatment groups. The investigators hypothesize that patients treated with metformin have a slower rate of RNFL thinning, and a slower rate of VF MD decline compared with those treated with placebo at similar levels of IOP over the 24-month follow-up. The proposed study has the potential to mark a paradigm shift in the management of glaucoma patients by demonstrating that neuroprotection is attainable with metformin, which will alleviate the increasing burden of glaucoma blindness in China and other Asian countries where glaucoma patients with normal levels of IOP are prevalent. Furthermore, it will inform and impact the study design in future neuroprotection trials which can expedite the development of neuroprotective therapy for glaucoma.
The 2 groups in the trial
- MetforminExisting treatment, for comparison
Oral administration
- PlaceboPlacebo, for comparison
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Metformin as a Neuroprotective Therapy for Glaucoma - A Randomized Controlled Trial
- Plain-language title
- Tests metformin to protect the optic nerve in glaucomaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 20 November 2025