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Age-Related Macular DegenerationPhase 2METforMINNCT02684578

Metformin for the Minimization of Geographic Atrophy Progression in Patients With AMD

A Phase 2 study testing Metformin in people with Age-Related Macular Degeneration and Macular Degeneration, Age-Related, run by University of California, San Francisco at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether metformin, an FDA-approved drug for the treatment of type II diabetes, is a safe and effective treatment to decrease the progression of geographic atrophy in non-diabetic patients with Age-related Macular Degeneration (AMD). Read more about this study

Who is it for?
Ages 55 years and older
What is being tested?
Metformin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
12 sitesUnited States
Study dates
Apr 2016to Oct 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject must be >/= 55 years of age
  • Subject must have evidence of advanced dry AMD, defined by the characteristic presence of drusen and/or pigmentary changes as well as geographic atrophy
  • Subject must have clear ocular media and adequate pupillary dilation
  • Subject must be able to swallow capsules
  • Study eye must have best corrected visual acuity (BCVA) of 20/20-20/400
  • Subject must be willing and able to pay for monthly prescription of Metformin HCl for 18 months in the event that their insurance carrier will not cover the cost of the drug

Who cannot join

  • Subjects with insufficient baseline size of geographic atrophy, less than 1.25 mm2 (0.5 Macular Photocoagulation Study Disc Areas). GA is defined as one or more well-defined and often circular patches of partial or complete depigmentation of the RPE, typically with exposure of underlying choroidal blood vessels. Even if much of the RPE appears to be preserved and large choroidal vessels are not visible, a round patch of RPE partial depigmentation may be classified as early GA. The GA in the study eye must be able to be photographed in its entirety, and it must not be contiguous with any areas of peripapillary atrophy, which can complicate area measurements.
  • Subjects who are already taking metformin for another purpose
  • Subjects with type 1 or 2 diabetes
  • Subjects with compromised kidney function:
  • Serum creatinine ≥1.5 mg/dL for males and ≥1.4 mg/dL for females
  • Subjects with moderate to severe heart failure (Class III or IV, New York Heart Association Functional Classifications)
Show all 17Show fewer
  • Subjects with Child's class C cirrhosis
  • Evidence of retinal atrophy due to causes other than atrophic AMD.
  • Subjects who have had anti-VEGF injections or active choroidal neovascularization in the study eye during the last 12 months
  • Current evidence or history of ocular disorders in the study eye that in the opinion of the investigator confounds study outcome measures, including (but not limited to):
  • Non-proliferative diabetic retinopathy involving 10 or more hemorrhages or microaneurysms, or active proliferative diabetic retinopathy
  • Branch or central retinal vein or artery occlusion
  • Macular hole
  • Pathologic myopia
  • Uveitis
  • Pseudovitelliform maculopathy
  • Intraoperative surgery within the last 90 days prior to study eye enrollment

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Austin Retina Associates

    Austin, Texas, 78705

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • University of California, Davis

    Davis, California, 95616

  • Retina Health Center

    Fort Myers, Florida, 33907

  • Palo Alto Veteran Affairs Medical Center

    Palo Alto, California, 94304

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Retinal Consultants Medical Group

    Sacramento, California, 95819

  • San Francisco Veteran Affairs Medical Center

    San Francisco, California, 94121

  • University of California San Francisco

    San Francisco, California, 94143

  • California Retina Consultants

    Santa Maria, California, 93454

  • North Bay Vitreoretinal Consultants

    Santa Rosa, California, 95403

Other trials in United States

About this study

Official title: METforMIN: Metformin Administration for the Minimization of Geographic Atrophy Progression in Patients With Age-related Macular Degeneration

The purpose of this study is to determine whether metformin, an FDA-approved drug for the treatment of type II diabetes, is a safe and effective treatment to decrease the progression of geographic atrophy in non-diabetic patients with Age-related Macular Degeneration (AMD).

Read the detailed description

This is a phase II, single-blind, randomized, evaluation of the safety and efficacy of metformin use to decrease geographic atrophy (GA) progression in non-diabetic patients with dry Age-related Macular Degeneration (AMD). Approximately 186 study subjects throughout four separate study sites will be randomized in a 1:1 ratio to the treatment group and the observation group. The treatment group will be assigned to the study intervention (oral Metformin) for 18 months while the observation group will receive no intervention for 18 months, instead continuing with standard of care ophthalmic exams and close monitoring of their disease. There will be one additional follow up visit at 24 months. Throughout the 24 month study period, the progression of subjects' GA or drusen growth will be measured via ocular imaging taken at standard of care follow-up examinations, including fundus autofluorescence imaging, optical coherence tomography (OCT), and fundus photography.

Being tested
Metformin
Medical subject headings
Macular Degeneration, Geographic Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02684578
Study groupRoleWhat they receive
MetforminExperimentalThis 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.
Receives: Drug: Metformin
ObserveNo interventionThis 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fundus Autofluorescence Imaging to Measure the Rate of Change in Area of Geographic Atrophy

    The primary efficacy endpoint was the annualized growth rate of the square root of geographic atrophy (GA) area in mm/year in the study eye as imaged by fundus autofluorescence (FAF) imaging. Change = (Month 18 GA Area - Baseline GA Area).

    Measured: 0 months, 18 months

Secondary outcomes (4)

  1. Change in Best Corrected Visual Acuity (BCVA)

    BCVA is the best possible vision an eye can see with corrective lenses and is measured as then number of letters read on the ETDRS chart. Change = (Month 18 Score - Baseline Score).

    Measured: 0 months, 18 months

  2. Change in Low-luminance Visual Acuity (LLVA)

    LLVA involves standard BCVA testing in low-light conditions, which is achieved by adding a neutral density filter in front of the eye being tested. LLVA is measured as the number of letters read on the ETDRS chart. This measure has been shown to correlate well with enlargement of GA. Change = (Month 18 Score - Baseline Score).

    Measured: 0 months, 18 months

  3. Ocular Safety as Measured by the Presence of Novel Intraocular Inflammation Judged by the Investigator to be Due to the Study Drug Metformin

    Subjects assigned to the Metformin study arm will be assessed at each follow-up eye exam to confirm ocular safety of metformin. The Data Safety and Management Board for this study will also assess the safety of metformin at different time points throughout the study. They will formally meet to discuss study subject safety at 25% enrollment and 75% enrollment. The potential for ocular side effects due to metformin is thought to be very low, due to the large number of diabetic patients who take this drug and are followed closely for diabetic retinopathy or other ocular disease.

    This outcome measures the number of treatment arm patients who experienced adverse ocular events during 1 or more follow-up visits.

    Measured: 0 months, 6 months, 12 months, 18 months, 24 months

  4. Systemic Safety as Measured by Presence of Side Effects Listed on Metformin Drug Label as "Severe"

    These include:

    Infrequent side effects of metformin (severe):

    • Trouble Breathing

    Rare side effects of metformin (severe):

    • Increased Blood Acidity due to High Levels of Lactic Acid (Lactic acidosis)
    • Low Blood Sugar
    • Megaloblastic Anemia
    • Reaction due to an Allergy

    Subjects assigned to the Metformin study arm will be assessed for these side-effects at each follow-up eye exam to confirm ocular safety of metformin. The Data Safety and Management Board for this study will also assess the safety of metformin at different time points throughout the study. They will formally meet to discuss study subject safety at 25% enrollment and 75% enrollment.

    This outcome measures the number of treatment arm patients who experienced side effects listed on Metformin drug label as "severe" during 1 or more follow-up visits.

    Measured: 0 months, 6 months, 12 months, 18 months, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionApr 2022
  4. Study completionOct 2022

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02684578
Sponsor's protocol ID
15-18258
Acronym
METforMIN
Status last verified
May 2023
First submitted
9 Feb 2016
Last updated
9 Jun 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Metformin in people with Age-Related Macular Degeneration and Macular Degeneration, Age-Related, run by University of California, San Francisco at 12 sites in United States.

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 6 inclusion and 17 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: finished, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fundus Autofluorescence Imaging to Measure the Rate of Change in Area of Geographic Atrophy (time frame: 0 months, 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02684578.

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 9 Jun 2023.

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