Effect of Metformin on Visual Function in Patients With Glaucoma

NCT04155164 | Unknown DMC

• 1 other identifier: 2019KYPJ130
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Open Angle Glaucoma

Keywords

Primary Open Angle Glaucoma; Metformin; Visual function

Outcome Measures

Primary Outcomes (1)

• Visual field

  to measure the change in visual field loss

  0 months, 12 months

Secondary Outcomes (4)

• Changes in best corrected visual acuity (BCVA)

  0 months, 6 months, 12 months

• Changes in retinal RNFL thickness

  0 months, 6 months, 12 months

• Changes in retinal cup/disk ratio

  0 months, 6 months, 12 months

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

  0 months, 6 months, 12 months

Study Arms (2)

Metformin

EXPERIMENTAL

Participants will receive Metformin for 12 months.

Drug: Metformin

Placebo

PLACEBO COMPARATOR

Participants will receive placebo for 12 months.

Drug: Placebos

Interventions

Metformin DRUG

Participants will receive Metformin at 1000mg for 12 months.

Also known as: Glucophage

Metformin

Placebos DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Blood sample should meet the following criteria: (no blood transfusion within 14 days) A. Hemoglobin (\> 90g/L); B. Platelet count (\>105\*10e9/L)
• Biochemical and urinary examinations should meet the following criteria:
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You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Metformin

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Xialin Liu, Prof.

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• Xing Liu, Prof.

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xialin Liu, Prof.

CONTACT

(020)66610720; liuxialin@gzzoc.com

Tian Zhou, Dr

CONTACT

(020)66610720; zhoutian@gzzoc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and researchers are double-blind. After signing informed consent, subjects who meet the inclusion criteria will be randomly divided into the oral Metformin experimental group or the oral placebo control group at a ratio of 1:1. Random lists will be generated by independent statisticians. Randomized group will be sealed in a separate opaque envelope, showing only the research identification number. Participants and researchers (medical evaluators, outcome evaluators and data analysts) will be unaware of the grouping. During the period of treatment, if patient suffers from lactic acidosis, excessive ventilation, myalgia, the masking should be unveiled and his/her systematic and eye conditions should be assessed to choose the best treatment. The choice of remedial treatment plan is based on the consensus of doctors and patients. The changes of treatment methods and curative effect should be recorded in detail for future analysis
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 7, 2019
• Study Start: December 10, 2019
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2024
• Last Updated: February 11, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)