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Gyrate Atrophy Ocular and Systemic Study

Study acronym: GYROS
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

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  1. 3 versions Re-verified since Sep 2, 2025, no change to tracked fieldsv36-v38
  2. Enrollment target: estimated 45 to confirmed 46
    • Study completion date: Jun 30, 2029 to Dec 31, 2028
    v35
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 11 of 11 sites
    v34
  4. Study sites: 12 to 11v33
  5. Site details revised at 3 of 12 sitesv32
Show 30 earlier versionsHide 30 earlier versions
  1. Site details revised at 3 of 12 sitesv31
  2. Re-verified, no change to tracked fieldsv30
  3. Study sites: 10 to 12v29
  4. Re-verified, no change to tracked fieldsv28
  5. Primary completion date: Aug 31, 2027 to Dec 31, 2028
    • Study completion date: Jan 31, 2028 to Jun 30, 2029
    • Collaborators: 1 to 2
    v27
  6. Collaborators: 3 to 1v26
  7. Collaborators: 2 to 3v25
  8. Collaborators: 3 to 2v24
  9. Site details revised at 2 of 10 sitesv23
  10. Study sites: 11 to 10v22
  11. Site details revised at 4 of 11 sitesv21
  12. Site details revised at 1 of 11 sitesv20
  13. Site details revised at 1 of 11 sitesv19
  14. Site contacts updated at 1 of 11 sitesv18
  15. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 31, 2023 to Nov 21, 2023
    • Site details revised at 11 of 11 sites
    v17
  16. Re-verified, no change to tracked fieldsv16
  17. Start date: Aug 30, 2023 to Oct 31, 2023v15
  18. Site contacts updated at 3 of 11 sitesv14
  19. Study sites: 10 to 11v13
  20. Start date: May 30, 2023 to Aug 30, 2023
    • Study sites: 12 to 10
    v12
  21. Site contacts updated at 2 of 12 sitesv11
  22. Site contacts updated at 9 of 12 sitesv10
  23. Start date: May 1, 2023 to May 30, 2023v9
  24. Start date: Mar 7, 2023 to May 1, 2023
    • Site contacts updated at 1 of 12 sites
    v8
  25. Study sites revised (12)v7
  26. Re-verified, no change to tracked fieldsv6
  27. Start date: Jan 2, 2023 to Mar 7, 2023
    • Site contacts updated at 1 of 12 sites
    v5
  28. Study sites: 0 to 12
    • Collaborators: 1 to 3
    v4
  29. Primary endpoints: 3 to 4
    • Secondary endpoints expanded, about 120 words
    v3
  30. Eligibility criteria expanded, about 8 words
    • Study description shortened, about 2 words
    v2
  1. Study First Submitted
  • 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.
The Gyrate Atrophy Ocular and Systemic Study characterizes the natural history of ornithine levels and retinal degeneration (RD) associated with disease-causing OAT variants in the presence of standard care dietary treatment regimens over 4 years. The research goal is to understand the impact of OAT mutations on plasma ornithine levels and retinal degeneration. Funding Source- FDA OOPD
Trial Details
NCT Number NCT05312736
Lead Sponsor Jaeb Center for Health Research
Collaborators: Conquering Gyrate Atrophy Foundation, Foundation Fighting Blindness
Conditions
(from sponsor)		 Gyrate Atrophy, Gyrata of Choroid and Retina; Atrophy, Ornithine-δ-aminotransferase, OAT, Chorioretinal Degeneration
Related terms Atrophy, Gyrate Atrophy
Enrollment 46 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov