Longitudinal Observational Study of Diabetic Retinopathy Progression in Type 2 Diabetes Patients

Sponsor
Association for Innovation and Biomedical Research on Light and Image
Study ID
NCT07458516
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
35 Years - 80 Years
Healthy Volunteers
Not accepted

Study Details

The purpose of this clinical study is to explore imaging, functional and systemic biomarkers of diabetic retinopathy (DR) progression, in Type 2 Diabetes (T2D) patients with moderate to severe non-proliferative diabetic retinopathy (NPDR) and mild proliferative diabetic retinopathy (PDR) using state of the art methodologies, commonly applied in clinical practice, over a period of two years. This study will provide longitudinal data to better understand retinal changes in moderate to severe diabetic retinopathy and early proliferative diabetic retinopathy and help guide timely interventions to prevent vision loss.

Key Dates

First listed
Mar 9, 2026
Start date
Nov 24, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
100 participants (estimated)

Primary Outcome Measure

Changes in capillary skeletonized vessel density (SVD) [ Time Frame: Baseline to 24 months ]

Central Contacts

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Type 2 diabetes trialsDiabetic retinopathy trialsEndocrinology trialsMetabolic health trialsWeight loss trialsOphthalmology trialsRetina trials

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