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Oral Metformin for Stargardt Disease
Study 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.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2010 Phase 4 trial • 77 Patients • NCT01589445Trial Design
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- 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.
- Group 1: Metformin
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Does this experiment accept enrollment of participants at the moment?
"Affirmative. The clinical trial is open for business, based on the information available from clinicaltrials.gov - beginning 11/23/2020 and last updated 8/9/2022. 38 participants are sought at a single medical site."
What is the current enrollment size for this research endeavor?
"Affirmative. According to clinicaltrials.gov, this trial is currently enrolling participants and was initially posted on November 23rd 2020 with an update as recent as August 9th 2022. 38 patients are needed across a singular site for enrollment purposes."
What purposes is this research trying to fulfill?
"The primary metric of this trial, evaluated over pre-treatment, baseline and month 24 intervals is the rate of growth for square-root transformed area EZ band loss (square-root AreaEZloss). Secondary objectives include assessing the proportion participants that experience a 30% reduction in their square root AreaEZloss from OCT during treatment phase compared to pre-treatment stage. There will also be an analysis into systemic and ocular toxicities as well as infections related to the intervention throughout the study period. Lastly, there will be assessment of how much region atropy measurements change between pre-and post treatment phases."
To what afflictions has Metformin hydrochloride been routinely applied?
"Metformin hydrochloride is a viable option for treating exercise-induced fatigue, Type 1 diabetes Mellitus and Diabetic Ketoacidosis."
Could you elucidate the research history of Metformin hydrochloride?
"As of now, there are 170 active clinical studies for Metformin hydrochloride with 43 trials in the advanced stage. Most investigations into this medication are occurring in Pittsburgh, Pennsylvania; however 1903 other locations also offer research opportunities related to Metformin hydrochloride."
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Average response time
- < 2 Days
Most responsive sites:
- National Institutes of Health Clinical Center: < 48 hours
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