Analysis of DR Progression to Identify Risks and Need for Treatment

Sponsor
Association for Innovation and Biomedical Research on Light and Image
Study ID
NCT07417410
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
35 Years - 90 Years
Healthy Volunteers
Not accepted

Study Details

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?

Key Dates

First listed
Feb 18, 2026
Start date
Nov 3, 2025
Status verified
Feb 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2027

Study Design

Enrollment
1,000 participants (estimated)

Primary Outcome Measure

Change in Diabetic Retinopathy Staging [ Time Frame: Baseline to 12 months ]

Central Contacts

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Diabetic retinopathy trialsOphthalmology trialsRetina trials

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