CClinicalTrials.gg
Status unknownNCT04155164Updated Feb 11, 2022

Effect of Metformin on Visual Function in Patients With Glaucoma

An interventional study of Metformin and Placebos in Primary Open Angle Glaucoma, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-02-11.

Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to determine whether Metformin could prevent the progression of glaucoma in a safe and effective manner.

Read the detailed description

Primary open-angle glaucoma (POAG) is a serious blinding disease characterized by irreversible damage to retinal ganglion cells (RGCs). At present, there is no effective treatment for the rescue of visual function loss caused by POAG.

Metformin is the classic first-line therapy for diabetes. Recently, it has been found that Metformin may have other beneficial effects such as promoting weight loss and reversing age-related neurodegeneration. Importantly, retrospective case-control studies found that there were associations between Metformin treatment and a reduction in the incidence of glaucoma. Specifically, diabetic patients treated by Metformin had a 25% lower risk to develop open-angle glaucoma. In addition, previous animal experiments have preliminarily shown that Metformin can play a neuroprotective role by activating AMPK kinase, regulating methylation levels and promoting ganglion cell survival. Therefore, the investigators hypothesize that Metformin can prevent visual function deterioration via rescuing retinal ganglion cells.

The main objective of this study is to assess the progression of visual field loss in patients with POAG after treatment with Metformin versus placebo. The secondary objectives include the followings: RNFL thickness, vision, cup/disk ratio, safety, and biochemical tests to determine the alteration of AMPK and methylation parameters associated to the use of Metformin.

Approximately 40 study subjects will be randomized in a 1:1 ratio to each treatment group. The treatment group will be assigned to the study intervention (oral Metformin) for 12 months while the placebo group will receive placebo containing fructose and starch for 12 months. Throughout the 12-month study period, progression of visual function and systematic safety examinations will be measured. At 18 months, there will be one additional follow up visit.

02

Conditions studied

  • Primary Open Angle Glaucoma

Keywords

  • Primary Open Angle Glaucoma
  • Metformin
  • Visual function
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's planned enrollment of 40 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 159 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age between 18-65 years old;
  • The baseline value of intraocular pressure ≤ 21 mmHg in either eye whether untreated or treated by ≤ 2 eye drops (laser or filtering surgery should be performed over 3 months).
  • Over two times of experience of visual field examination (24-2 or 30-2 visual field examinations) in the past two years, or false positive/false negative ratio less than 33%;
  • Diagnosed POAG by Glaucoma specialists from Zhongshan Ophthalmic Center with open angle, and impairment in optic disc or visual field in one or both eyes.
  • Patient is at risk of glaucomatous progression, as determined by the documented presence of optic disc hemorrhage within 12 months in either eye, OR ≥2 of the following risk factors:
  • Vertical cup-to-disc ratio >0.8 in one or both eyes
  • Mean deviation in visual field worse than \<10 dB in either eye (verified by the reading center)
  • Pseudoexfoliation in either eye
  • Family history (parent or sibling) of glaucoma
  • Hypertension
  • Systemic hypertension requiring medical treatment Migraine (defined by the International Headache Society with or without aura, Raynaud's syndrome, or both:
  • The main organs are functioning normally and meet the following criteria:

    1. Blood sample should meet the following criteria: (no blood transfusion within 14 days) A. Hemoglobin (> 90g/L); B. Platelet count (>105*10e9/L)
    2. Biochemical and urinary examinations should meet the following criteria:

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    1. . Urine bilirubin \< 1.25 times ULN (Upper Limit of Normal);
    2. . ALT and AST \< 2.5 times ULN;
    3. . CREA ≤ ULN;

Exclusion criteria

Exclusion criteria:

  • Secondary open-angle glaucoma (such as pigmentation syndrome, trauma, etc.) or angle-closure glaucoma.
  • The best corrected visual acuity of either eye is less than 6/36;
  • The mean derivation of visual field in either eye is less than - 22dB.
  • Use of >2 topical (or any oral) IOP-lowering products at the baseline visit.
  • Any ocular pathology in either eye that may have interfered with the ability to obtain visual field, disc imaging, or accurate IOP readings such as uveitis, refractive opacification;
  • Eye drops such as neuroprotective therapies have been used in the past three weeks might affect this clinical study, for inclusion need 8 weeks of wash period.
  • Pregnant or nursing women;
  • Diabetes mellitus, definite impairment of liver and kidney function, or severe heart, liver or kidney diseases;
  • In the last three months, ophthalmic surgery (including cataract surgery) has been performed
  • Enrolled in other clinical study at the same time.
  • Could not complete the study according to the requirements in this research .
  • History of epilepsy or severe mental illness, including schizophrenia, bipolar disorder or severe depression
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Metformin

    Participants will receive Metformin for 12 months.

    Drug: Metformin

  • Placebo comparator
    Placebo

    Participants will receive placebo for 12 months.

    Drug: Placebos

Interventions

  • DrugMetformin

    Participants will receive Metformin at 1000mg for 12 months.

    Also known as: Glucophage

  • DrugPlacebos

    Placebo group will take Placebo at 1000mg for 12 months.

06

What researchers measure

Primary outcomes

  1. Visual field

    to measure the change in visual field loss

    Time frame: 0 months, 12 months

Secondary outcomes

  1. Changes in best corrected visual acuity (BCVA)

    to measure the change in visual acuity

    Time frame: 0 months, 6 months, 12 months

  2. Changes in retinal RNFL thickness

    to meausre the thickness of retinal RNFL by OCT

    Time frame: 0 months, 6 months, 12 months

  3. Changes in retinal cup/disk ratio

    to measure the alterations in retina cup/disk ratio

    Time frame: 0 months, 6 months, 12 months

  4. Systemic safety as measured by presence of side effects listed on Metformin drug label as "severe"

    These include: Infrequent side effects of Metformin (severe):Dyspnea; Rare side effects of Metformin (severe):Lactic acidosis; Hypoglycemia; Megaloblastic Anemia; Allergic reactions. The participants will be assessed for these side-effects at each follow-up ocular exam to confirm ocular and systematic safety of Metformin. Blood samples will be collected at 0 month, 6 months, and 12 months to value AMPK, methylation level and inflammatory responses. The Data Monitoring Committee for this study will also assess the safety of Metformin at different time points throughout the study.

    Time frame: 0 months, 6 months, 12 months

07

Study locations

1 of 1 sites recruiting
  • Zhongshan Ophthalmic Center
    Guangzhou, Guangdong 510000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04155164
Lead sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Responsible party
Sponsor
First posted
Nov 7, 2019
Start date
Dec 10, 2019
Primary completion
May 2022 (estimated)
Completion
May 2024 (estimated)
Last update
Feb 11, 2022

Study contacts

Xialin Liu, Prof.
Contact
liuxialin@gzzoc.com
(020)66610720
Tian Zhou, Dr
Contact
zhoutian@gzzoc.com
(020)66610720
Xialin Liu, Prof.
principal investigator · Zhongshan Ophthalmic Center, Sun Yat-sen University
Xing Liu, Prof.
principal investigator · Zhongshan Ophthalmic Center, Sun Yat-sen University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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