Effect of Metformin on Visual Function in Patients With Glaucoma

Last updated: February 10, 2022
Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Glaucoma

Open Angle Glaucoma

Treatment

N/A

Clinical Study ID

NCT04155164
2019KYPJ130
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age between 18-65 years old;
  • The baseline value of intraocular pressure ≤ 21 mmHg in either eye whether untreatedor treated by ≤ 2 eye drops (laser or filtering surgery should be performed over 3months).
  • Over two times of experience of visual field examination (24-2 or 30-2 visual fieldexaminations) in the past two years, or false positive/false negative ratio less than 33%;
  • Diagnosed POAG by Glaucoma specialists from Zhongshan Ophthalmic Center with openangle, and impairment in optic disc or visual field in one or both eyes.
  • Patient is at risk of glaucomatous progression, as determined by the documentedpresence of optic disc hemorrhage within 12 months in either eye, OR ≥2 of thefollowing 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 thereading center)
  • Pseudoexfoliation in either eye
  • Family history (parent or sibling) of glaucoma
  • Hypertension
  • Systemic hypertension requiring medical treatment Migraine (defined by theInternational 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 14days) A. Hemoglobin (> 90g/L); B. Platelet count (>105*10e9/L)
  2. Biochemical and urinary examinations should meet the following criteria:
  3. . Urine bilirubin < 1.25 times ULN (Upper Limit of Normal);
  4. . ALT and AST < 2.5 times ULN;
  5. . CREA ≤ ULN;

Exclusion

Exclusion criteria:

  • Secondary open-angle glaucoma (such as pigmentation syndrome, trauma, etc.) orangle-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 obtainvisual field, disc imaging, or accurate IOP readings such as uveitis, refractiveopacification;
  • Eye drops such as neuroprotective therapies have been used in the past three weeksmight 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 beenperformed
  • 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, bipolardisorder or severe depression

Study Design

Total Participants: 40
Study Start date:
December 10, 2019
Estimated Completion Date:
May 31, 2024

Study 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.

Connect with a study center

  • Zhongshan Ophthalmic Center

    Guangzhou, Guangdong 510000
    China

    Active - Recruiting

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