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Biguanide

Metformin for Macular Degeneration (METforMIN Trial)

Phase 2
Waitlist Available
Led By Jay M Stewart, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 months, 6 months, 12 months, 18 months, 24 months
Awards & highlights

METforMIN Trial Summary

This trial will test whether metformin is a safe and effective treatment to decrease the progression of geographic atrophy in non-diabetic patients with Age-related Macular Degeneration.

Eligible Conditions
  • Macular Degeneration
  • Age-Related Macular Degeneration

METforMIN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 months, 6 months, 12 months, 18 months, 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 months, 6 months, 12 months, 18 months, 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fundus Autofluorescence Imaging to Measure the Rate of Change in Area of Geographic Atrophy
Secondary outcome measures
Change in Best Corrected Visual Acuity (BCVA)
Change in Low-luminance Visual Acuity (LLVA)
Ocular Safety as Measured by the Presence of Novel Intraocular Inflammation Judged by the Investigator to be Due to the Study Drug Metformin
+1 more

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221
13%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Squamous cell carcinoma of the tongue
1%
Femoral neck fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo

METforMIN Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MetforminExperimental Treatment1 Intervention
This arm will be receiving the study drug, Metformin, for the duration of the 24 month study. They will begin this drug on a low dose of Metformin, increasing the dosage in a step-wise fashion to avoid unwanted gastrointestinal discomfort, a common side effect when patients begin taking Metformin. During the 24 month study, subjects assigned to this arm will have 4 follow-up exams after the initial enrollment exam, at 6 month intervals.
Group II: ObserveActive Control1 Intervention
This arm will maintain standard of care for dry AMD, which is observation. During the 24 month study, subjects assigned to this arm will have 4 follow-up exams after the initial enrollment exam, at 6 month intervals.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430

Find a Location

Who is running the clinical trial?

University of California, IrvineOTHER
544 Previous Clinical Trials
1,922,977 Total Patients Enrolled
1 Trials studying Macular Degeneration
23 Patients Enrolled for Macular Degeneration
University of California, Los AngelesOTHER
1,530 Previous Clinical Trials
10,264,621 Total Patients Enrolled
6 Trials studying Macular Degeneration
1,709 Patients Enrolled for Macular Degeneration
California Retina ConsultantsOTHER
12 Previous Clinical Trials
1,086 Total Patients Enrolled
4 Trials studying Macular Degeneration
173 Patients Enrolled for Macular Degeneration

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions has Metformin been demonstrated to alleviate?

"Metformin is commonly employed to treat diabetes and its associated symptoms. It has also been found useful for treating polycystic ovary syndrome as well as exercise-related conditions."

Answered by AI

To what degree can Metformin be deemed hazardous to individuals?

"Metformin has been proven to have a measure of safety, hence receiving a score of 2. However, since this is only Phase 2 clinical trial data, its efficacy cannot be determined yet."

Answered by AI

Has research been conducted into Metformin previously?

"George Washington University initiated the first investigation into Metformin in 2002, and since then 1095 research studies have been finalized. Currently, there are 170 ongoing trials, with a large portion of them taking place around Sacramento, Oregon."

Answered by AI

How many individuals are receiving treatment through this medical trial?

"This clinical trial is no longer actively recruiting participants. Originally posted in April 2016, the study was last updated on August 1st, 2022. Alternately, one can find 319 trials researching geographic atrophy and 170 studies involving Metformin currently enrolling patients."

Answered by AI

Is enrolment for this research still open?

"Per the information provided on clinicaltrials.gov, this trial is no longer actively enrolling patients. It was first posted in April 2016 and its last update was on August 1st 2022; however, there are presently 489 other trials that still require participants."

Answered by AI

How many sites have been designated for this experimental research?

"This research is taking place at Retinal Consultants Medical Group in Sacramento, Oregon Health and Science University in Portland, and San Francisco Veteran Affairs Medical Center in San Francisco. Furthermore there are 13 other sites involved with the study."

Answered by AI

Who else is applying?

What state do they live in?
Texas
California
How old are they?
18 - 65
What site did they apply to?
Retinal Consultants Medical Group
San Francisco Veteran Affairs Medical Center
North Bay Vitreoretinal Consultants
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Third generation of macular degeneration. I want to help this change.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How much commitment/time will it be? What happens if I have a bad reaction to the drug?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Metformin for the Minimization of Geographic Atrophy Progression in Patients With AMD
2016. "Metformin for the Minimization of Geographic Atrophy Progression in Patients With AMD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02684578.
~7 spots leftby Apr 2025
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