Primary Open Angle GlaucomaNCT04155164
Effect of Metformin on Visual Function in Patients With Glaucoma
A study testing Metformin in people with Primary Open Angle Glaucoma, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to determine whether Metformin could prevent the progression of glaucoma in a safe and effective manner. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Open Angle Glaucoma
- What is being tested?
- Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2019to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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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- . Urine bilirubin < 1.25 times ULN (Upper Limit of Normal);
- . ALT and AST < 2.5 times ULN;
- . CREA ≤ ULN;
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, 510000
Tian Zhou, phD, zhoutian@gzzoc.com
About this study
Official title: Effect of Metformin on Visual Function in Patients With Primary Open Angle Glaucoma: A Randomized Control Study
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.
- Conditions
- Primary Open Angle Glaucoma
- Being tested
- Metformin, Placebos
- Keywords
- Primary Open Angle Glaucoma, Metformin, Visual function
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glucophage
Participants will receive Metformin at 1000mg for 12 months.
PlacebosDrug
Placebo group will take Placebo at 1000mg for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | Participants will receive Metformin for 12 months. Receives: Drug: Metformin |
| Placebo | Placebo comparator | Participants will receive placebo for 12 months. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual field
to measure the change in visual field loss
Measured: 0 months, 12 months
Secondary outcomes (4)
Changes in best corrected visual acuity (BCVA)
to measure the change in visual acuity
Measured: 0 months, 6 months, 12 months
Changes in retinal RNFL thickness
to meausre the thickness of retinal RNFL by OCT
Measured: 0 months, 6 months, 12 months
Changes in retinal cup/disk ratio
to measure the alterations in retina cup/disk ratio
Measured: 0 months, 6 months, 12 months
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.
Measured: 0 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start10 Dec 2019
- Primary completionMay 2022 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xialin Liu, Prof., Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityXing Liu, Prof., Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155164
- Sponsor's protocol ID
- 2019KYPJ130
- Status last verified
- Feb 2022
- First submitted
- 1 Nov 2019
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Metformin on Visual Function in Patients With Primary Open Angle Glaucoma: A Randomized Control Study
- ClinicalTrials.gov ID
- NCT04155164
- Acronym / sponsor ID
- 2019KYPJ130
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- Primary Open Angle Glaucoma, Metformin, Visual function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 7 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Metformin could prevent the progression of glaucoma in a safe and effective manner.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: MetforminParticipants will receive Metformin for 12 months. |
| Placebo | Placebo comparator | Drug: PlacebosParticipants will receive placebo for 12 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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:
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminAlso: GlucophageParticipants will receive Metformin at 1000mg for 12 months. | Drug | Metformin |
| PlacebosPlacebo group will take Placebo at 1000mg for 12 months. | Drug | Placebo |
Primary outcome
Visual field
Time frame: 0 months, 12 months
to measure the change in visual field loss
4 secondary outcomes
Changes in best corrected visual acuity (BCVA)
Time frame: 0 months, 6 months, 12 months
Changes in retinal RNFL thickness
Time frame: 0 months, 6 months, 12 months
Changes in retinal cup/disk ratio
Time frame: 0 months, 6 months, 12 months
Systemic safety as measured by presence of side effects listed on Metformin drug label as "severe"
Time frame: 0 months, 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xialin Liu, Prof. principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
Xing Liu, Prof. principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin in people with Primary Open Angle Glaucoma, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xialin Liu, Prof. ((020)66610720, liuxialin@gzzoc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual field (time frame: 0 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2022.