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NCT04545736 · ClinicalTrials.gov registry record · Phase 1
Oral Metformin for Treatment of ABCA4 Retinopathy
A Phase 1 study of Retinal Degeneration and Stargardt Disease, sponsored by National Eye Institute (NEI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
- 2
- Study locations
NCT04545736: Recruiting Phase 1 study of Retinal Degeneration and Stargardt Disease, sponsored by National Eye Institute (NEI).
NCT04545736 is a Phase 1 study of Retinal Degeneration and Stargardt Disease that is actively recruiting participants, run by National Eye Institute (NEI). The registered enrollment target is 56 participants, below the 338-participant average among 17 other Retinal Degeneration trials with a reported enrollment target (83% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04545736, a Phase 1 study of Retinal Degeneration and Stargardt Disease, is actively recruiting participants, sponsored by National Eye Institute (NEI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
- 2
- Study locations
Study Summary
Background: ABCA4 retinopathy is a genetic disease in which the ABCA4 protein is absent or faulty. It can cause waste material to collect in the eye and may cause cells to die. The cell death can lead to vision loss. Researchers want to see if an oral drug called metformin can help. Objective: To see if metformin is safe and possibly helps to slow the rate of ABCA4 retinopathy. Eligibility: People age 12 and older who have ABCA4 retinopathy and have problems with their vision. Design: Participants will be screened under a separate protocol. Participants will have a medical and family history. They will complete a questionnaire about their vision and daily activities. They will have a physical exam. They may have blood drawn through a needle in the arm. Participants will have an eye exam. Their pupils may be dilated with eye drops. Their retina may be photographed. Participants will have a visual field test. They will sit in front of a large dome and press a button when they see a light within the dome. Participants will have an electroretinogram. It examines the function of the retina. They will sit in the dark for 30 minutes. Then their eyes will be numbed with eye drops. They will wear contact lenses that can sense signals from the retinas. They will watch flashing lights. Participants will have optical coherence tomography. This non-invasive procedure makes pictures of the retina. Participants will have fundus autofluorescence. A bright blue light will be shone into their eye. Participants will take metformin by mouth for 24 months. Participants will have study visits every 6 months. Participation will last for at least 36 months....
Primary Outcome
The difference in growth rate of vAreaEZloss, from OCT, between the pre-treatment phase and treatment phase.
Conditions Studied
Interventions
- DRUG Metformin hydrochloride
Study Locations (2)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2020-11-23 |
| Est. Completion | 2028-09-30 |
| Phase | Phase 1 |
What NCT04545736 shows while recruiting
NCT04545736 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 338-participant average among 17 other Retinal Degeneration trials with a reported enrollment target (83% lower).
The record links to 4 conditions, with Retinal Degeneration appearing as the primary indexed condition, and to 1 intervention - of which Metformin hydrochloride is the first listed.
NCT04545736 reports a single indexed study location in Maryland, Michigan.
Frequently Asked Questions
What is clinical trial NCT04545736 about?
NCT04545736 is a clinical study titled "Oral Metformin for Treatment of ABCA4 Retinopathy". Background: ABCA4 retinopathy is a genetic disease in which the ABCA4 protein is absent or faulty. It can cause waste material to collect in the eye and may cause cells to die. The cell death can lead to vision loss. Researchers want to see if an oral drug called metformin can help. Objective: To...
What is the current status of trial NCT04545736?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2020-11-23. Estimated completion is 2028-09-30.
What conditions does trial NCT04545736 study?
This clinical trial studies the following conditions: Retinal Degeneration, Stargardt Disease, Retinal Dystrophy, ABCA4 Retinopathy.
What interventions are being tested in trial NCT04545736?
The interventions under investigation include: Metformin hydrochloride (DRUG).
Who is sponsoring clinical trial NCT04545736?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04545736 being conducted?
This trial has 2 study locations across Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04545736's enrollment target sits among peer trials
56 8th of 17 higher than 10 of 17 other Retinal Degeneration trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Retinal Degeneration trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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