Clinical Trial

Prediction of Progression of Retinal Ischemia in Diabetes

Study acronym: PREDICTION
Active, Not Recruiting
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Summary
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2022-10-12; most recent amendment 2025-05-08.
Status change: Recruiting → Active, Not Recruiting 2024-03-19
Status change: Not Yet Recruiting → Recruiting 2022-12-21
Trial Details
NCT Number NCT05581225
Lead Sponsor Association for Innovation and Biomedical Research on Light and Image
Conditions Diabetic Retinopathy
Enrollment 62 participants
Start Date 2022-12-02
Primary Completion 2024-02-02 (estimated)
Study Completion 2028-10-31 (estimated)
Updated on ClinicalTrials.gov 2025-05-09