RecruitingNCT07417410

Analysis of DR Progression to Identify Risks and Need for Treatment

Sponsor

Association for Innovation and Biomedical Research on Light and Image

Enrollment

1,000 participants

Start Date

Nov 3, 2025

Study Type

OBSERVATIONAL

Conditions

Diabetic Retinopathy

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?

Eligibility

Min Age: 35 YearsMax Age: 90 Years

Inclusion Criteria4

Diagnosed with type 2 diabetes according to the 1985 WHO criteria.
Age between 35 and 90 years.
Retrospective visit or referenced patients. For the retrospective visit, a documented follow-up of 1-5 years is required, with at least one clinical visit. For the referenced patients, it is required that they have either diabetic retinopathy at the baseline visit, the presence of at least one cardiovascular risk factor at the baseline visit, or cardiovascular complications at the baseline visit.
Signed informed consent.

Exclusion Criteria6

Previous laser photocoagulation or intravitreal injections (consider if corticosteroids were administered).
Presence of clinically significant macular edema (CSME) with vision loss or requiring immediate treatment.
Proliferative diabetic retinopathy.
Any ocular surgery within the previous 3 months.
Renal Replacement Therapy (Hemodialysis, Peritoneal Dialysis).
Severe systemic illness, subject to investigator's judgment.

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