|

Analysis of DR Progression to Identify Risks and Need for Treatment

RECRUITINGSponsored by Association for Innovation and Biomedical Research on Light and Image
Actively Recruiting
SponsorAssociation for Innovation and Biomedical Research on Light and Image
Started2025-11-03
Est. completion2026-11
Eligibility
Age35 Years – 90 Years
Healthy vol.Accepted

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

Age: 35 Years – 90 YearsHealthy volunteers accepted
Inclusion Criteria:

* 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 Criteria:

* 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.

Conditions2

DiabetesDiabetic Retinopathy

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.