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Prediction of Progression of Retinal Ischemia in Diabetes

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

Record History

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  1. Re-verified, no change to tracked fieldsv7
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 52 to confirmed 62
    • Primary completion date changed from estimate of Feb 1, 2024 to Feb 2, 2024
    • Site details revised
    v6
  3. Primary completion date: Jan 31, 2028 to Feb 1, 2024
    • Enrollment target: 50 to 52
    v5
  4. Primary completion date: Oct 31, 2027 to Jan 31, 2028
    • Study completion date: Aug 31, 2028 to Oct 31, 2028
    v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 1, 2022 to Dec 2, 2022
    • Site details revised
    v3
  6. Primary endpoints revised (3)
    • Secondary endpoints: 4 to 7
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Diabetes Mellitus (DM) is a major public health problem with significant socioeconomic implications due to its increased prevalence. Diabetic retinopathy (DR) is the most frequent complication in DM patients and remains the leading cause of legal blindness in working-age populations (Yau et al., 2012). Differentiating patients with higher vs low risk of progression to vision-threatening complications is of paramount importance for an efficient managing of the disease to prevent vision disability. PREDICTION is a longitudinal prospective clinical study in DMT2 patients with a higher risk of progression to explore possible imaging, functional and systemic biomarkers of progression, using non-invasive methods, commonly applied in the clinical practice. Investigating the retinal vascular network (vessel density metrics with Optical Coherence Tomography Angiography) will allow a better understanding of the evolution of capillary closure and ischemia, two main risk factors for DR worsening.
Trial Details
NCT Number NCT05581225
Lead Sponsor Association for Innovation and Biomedical Research on Light and Image
Conditions
(from sponsor)		 Diabetic Retinopathy
Related terms Diabetic Retinopathy
Enrollment 62 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov