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Longitudinal Natural History Study of Retinal Function in Eyes of Patients With Diabetes

Study acronym: AR
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Study sites: 4 to 6
    • Eligibility criteria expanded, about 12 words
  2. Recruitment opened
    • Trial sites expanded: 0 → 4 locations
    • Start date changed from estimate of May 2, 2026 to Jun 1, 2026
    v3
  3. Primary completion date: Dec 2032 to Dec 2027
    • Start date: Dec 2, 2025 to May 2, 2026
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A considerable hurdle to the development of novel, more effective therapies for diabetic retinal disease is the limited number of primary endpoints available for use in regulatory trials. Current endpoints necessitate long trial durations and a greater number of participants to show efficacy. Thus, a better understanding of the structural and functional changes in the retina occurring in people with diabetes is essential for developing primary endpoints and validating surrogate and clinical endpoints.
Trial Details
NCT Number NCT07270133
Lead Sponsor Jaeb Center for Health Research
Collaborators: National Eye Institute (NEI)
Conditions
(from sponsor)		 Diabetic Retinal Disease
Enrollment 450 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov