Effect of Metformin on Visual Function in Patients With Glaucoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04155164|
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : December 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Primary Open Angle Glaucoma||Drug: Metformin Drug: Placebos||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
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
|Official Title:||Effect of Metformin on Visual Function in Patients With Primary Open Angle Glaucoma: A Randomized Control Study|
|Actual Study Start Date :||December 10, 2019|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 2021|
Participants will receive Metformin for 12 months.
Participants will receive Metformin at 1000mg for 12 months.
Other Name: Glucophage
Placebo Comparator: Placebo
Participants will receive placebo for 12 months.
Placebo group will take Placebo at 1000mg for 12 months.
- Visual field [ Time Frame: 0 months, 12 months ]to measure the change in visual field loss
- Changes in best corrected visual acuity (BCVA) [ Time Frame: 0 months, 6 months, 12 months ]to measure the change in visual acuity
- Changes in retinal RNFL thickness [ Time Frame: 0 months, 6 months, 12 months ]to meausre the thickness of retinal RNFL by OCT
- Changes in retinal cup/disk ratio [ Time Frame: 0 months, 6 months, 12 months ]to measure the alterations in retina cup/disk ratio
- Systemic safety as measured by presence of side effects listed on Metformin drug label as "severe" [ Time Frame: 0 months, 6 months, 12 months ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155164
|Contact: Xialin Liu, Prof.||(020)firstname.lastname@example.org|
|Contact: Tian Zhou, Dr||(020)email@example.com|
|Zhongshan Ophthalmic Center||Recruiting|
|Guangzhou, Guangdong, China, 510000|
|Contact: Tian Zhou, phD firstname.lastname@example.org|
|Principal Investigator:||Xialin Liu, Prof.||Zhongshan Ophthalmic Center, Sun Yat-sen University|
|Principal Investigator:||Xing Liu, Prof.||Zhongshan Ophthalmic Center, Sun Yat-sen University|