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Oral Metformin for Treatment of ABCA4 Retinopathy

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 215 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 35 words
  2. 4 versions Re-verified since Jun 19, 2026, no change to tracked fieldsv211-v214
  3. Trial status changed: Recruiting → Active, Not Recruitingv210 Show 4 more changesShow less
    • Primary completion moved earlier from Sep 30, 2028 to Feb 2, 2028
    • Study completion pushed from Sep 30, 2028 to Feb 2, 2029
    • Enrollment target: estimated 56 to confirmed 55
    • Site details revised at 2 of 2 sites
  4. 3 versions Re-verified since Oct 24, 2025, no change to tracked fieldsv207-v209
  5. Eligibility criteria revisedv206
Show 40 earlier versionsHide 40 earlier versions
  1. Eligibility criteria expanded, about 7 wordsv205
  2. Eligibility criteria shortened, about 65 wordsv204
  3. 5 versions Re-verified since Mar 12, 2025, no change to tracked fieldsv199-v203
  4. Primary and study completion dates: Aug 31, 2027 to Sep 30, 2028v198
  5. Re-verified, no change to tracked fieldsv197
  6. Eligibility criteria expanded, about 25 wordsv196
  7. Enrollment target: 45 to 56v195
  8. 5 versions Re-verified since Mar 1, 2024, no change to tracked fieldsv190-v194
  9. Eligibility criteria expanded, about 85 wordsv189
  10. Primary and study completion dates: Aug 31, 2026 to Aug 31, 2027
    • Study sites: 1 to 2
    v188
  11. Re-verified, no change to tracked fieldsv187
  12. Enrollment target: 38 to 45v186
  13. 3 versions Re-verified since Apr 15, 2023, no change to tracked fieldsv183-v185
  14. Eligibility criteria expanded, about 212 words
    • Study description shortened, about 236 words
    v182
  15. 3 versions Re-verified since Jul 15, 2022, no change to tracked fieldsv179-v181
  16. Study Status, Study Description, Eligibility, Contacts/Locationsv178
  17. 12 versions Re-verified since Jun 15, 2022, no change to tracked fieldsv166-v177
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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....
Trial Details
NCT Number NCT04545736
Lead Sponsor National Eye Institute (NEI)
Conditions
(from sponsor)		 ABCA4 Retinopathy, Stargardt Disease, Retinal Dystrophy, Retinal Degeneration
Related terms Retinal Degeneration, Retinal Dystrophies, Stargardt Disease
Enrollment 55 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov