Clinical Trial

Analysis of DR Progression to Identify Risks and Need for Treatment

Study acronym: ALERT
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Summary
The goal of this observational study is to understand whether vascular and structural changes in the eyes caused by diabetes can help predict which people are more likely to experience worsening diabetic retinopathy (a diabetes-related eye disease) and how these eye changes are related to cardiovascular complications. The study will include about 1,000 people with type 2 diabetes, aged 35 to 90 years, and will take place over twelve months. It may also include a retrospective component, where existing medical and imaging data collected from previous visits (within the last 1 to 5 years) will be analyzed. The main questions it aims to answer are: * Can eye vessel and tissue changes, observed through modern imaging techniques and clinical data, help better describe and predict which cases of diabetic retinopathy will become more severe? * Can these same eye changes help predict the presence and risk of cardiovascular problems-such as heart disease or stroke-in people living with type 2 diabetes?
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-02-10.
Trial Details
NCT Number NCT07417410
Lead Sponsor Association for Innovation and Biomedical Research on Light and Image
Collaborators: Fundação para a Ciência e a Tecnologia
Conditions Diabetic Retinopathy
Enrollment 1,000 participants
Start Date 2025-11-03
Primary Completion 2026-11 (estimated)
Study Completion 2027-11 (estimated)
Updated on ClinicalTrials.gov 2026-03-02