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Biguanide
Oral Metformin for Stargardt Disease
Phase 1 & 2
Recruiting
Led By Brian P Brooks, M.D.
Research Sponsored by National Eye Institute (NEI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 24
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether the drug metformin can help people with ABCA4 retinopathy, a disease which causes waste material to build up in the eye and can lead to vision loss.
Who is the study for?
This trial is for people aged 12 and older with ABCA4 retinopathy, a genetic eye condition leading to vision loss. Participants must have documented changes in their condition over two years and agree to lifestyle guidelines and contraception if of childbearing potential.
What is being tested?
The study tests whether metformin hydrochloride, an oral medication commonly used for diabetes, can slow down the progression of ABCA4 retinopathy when taken over a period of 24 months.
What are the potential side effects?
Metformin may cause side effects like stomach upset, diarrhea, nausea, and a rare risk of lactic acid buildup in the blood which can be serious. It's generally well-tolerated but monitoring is needed especially for kidney function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, month 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 24
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The difference in growth rate of square-root transformed area of EZ band loss (vAreaEZloss)
Secondary study objectives
Change in perimetry and color fundus photography measurements
Change in rate of area of atrophy enlargement
Changes in best corrected visual acuity (BCVA)
+2 moreSide effects data
From 2010 Phase 4 trial • 77 Patients • NCT015894455%
Weight gain
4%
Common Depression
3%
Abdominal discomfort
1%
Dizziness
1%
Peripheral Edema
1%
Backpain
1%
Headache
1%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pioglitazone (001 Group)
Metformin (002 Group)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: MetforminExperimental Treatment1 Intervention
Oral administration of metformin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin hydrochloride
2016
Completed Phase 4
~770
Find a Location
Who is running the clinical trial?
National Eye Institute (NEI)Lead Sponsor
555 Previous Clinical Trials
1,407,336 Total Patients Enrolled
3 Trials studying Stargardt Disease
590 Patients Enrolled for Stargardt Disease
Brian P Brooks, M.D.Principal InvestigatorNational Eye Institute (NEI)
5 Previous Clinical Trials
953 Total Patients Enrolled
1 Trials studying Stargardt Disease
68 Patients Enrolled for Stargardt Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have scarring in my eye from abnormal blood vessel growth.You have at least two years of natural history data with a rate of growth of square-root(Area(EZloss)) > 0.025 mm/year based on calculation from at least four data points.The time between each data point must be at least six months.I have specific genetic mutations linked to my condition.I am using metformin and following the required birth control measures.I am on medication that may not mix well with metformin.I have a history of chronic lactic acidosis or type 1 diabetes.I am at least 12 years old.I have a confirmed genetic mutation linked to Stargardt disease affecting both eyes.I have a history of severe kidney, liver, lung, or heart disease.I am using or willing to use approved birth control methods.I have been taking metformin for over a month.I am not pregnant, breastfeeding, or planning to become pregnant during the study.You are female and of childbearing potential.I agree to follow specific lifestyle guidelines during the study.You use hormonal birth control such as pills, injections, patches, or vaginal rings.
Research Study Groups:
This trial has the following groups:- Group 1: Metformin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Stargardt Disease Patient Testimony for trial: Trial Name: NCT04545736 — Phase 1 & 2
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