Finding eye changes that signal diabetic retinopathy progression and need for treatment
Analysis of DR Progression to Identify Risks and Need for Treatment
This study will try to see if specific retinal vessel and tissue changes measured with modern imaging can predict worsening diabetic retinopathy and cardiovascular risk in people aged 35 to 90 with type 2 diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 35 Years to 90 Years |
| Sex | All |
| Sponsor | Association for Innovation and Biomedical Research on Light and Image Academic / other |
| Locations | 1 site (Portugal, Coimbra District) |
| Trial ID | NCT07417410 on ClinicalTrials.gov |
What this trial studies
This observational project will enroll about 1,000 adults with type 2 diabetes (ages 35–90) and follow them over twelve months, with an optional retrospective review of 1–5 years of prior clinical and imaging data. Investigators will use advanced retinal imaging to quantify central and peripheral lesions and other vascular and structural biomarkers, and link those measures to diabetic retinopathy staging and progression. Clinical and demographic data will be combined with imaging findings to examine associations with cardiovascular risk factors and major adverse cardiovascular events (MACE). The collected and harmonized dataset is intended to support development of AI models and improve understanding of pathophysiologic links between retinal and systemic vascular disease.
Who should consider this trial
Good fit: Adults aged 35 to 90 with type 2 diabetes who can provide informed consent and have either diabetic retinopathy at baseline, at least one cardiovascular risk factor or cardiovascular complications at baseline, or documented follow-up data from the past 1–5 years are ideal candidates.
Not a fit: People with proliferative diabetic retinopathy, clinically significant macular edema requiring immediate treatment, recent ocular surgery, prior retinal laser or intravitreal injections, or on renal replacement therapy are excluded and unlikely to benefit from this observational protocol.
Why it matters
Potential benefit: If successful, the findings could help clinicians identify people with type 2 diabetes at higher risk of vision loss or heart problems earlier, enabling more targeted monitoring or preventive care.
How similar studies have performed: Previous observational work has shown retinal imaging biomarkers can correlate with DR progression and cardiovascular risk, though combining central versus peripheral lesion analysis with a harmonized AI-ready dataset at this scale is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Portugal, Coimbra District
- AIBILI-Clinical Trial Centre — Portugal, Coimbra District, Portugal (Recruiting)
Study contacts
- Study coordinator: Joana F Tavares, PhD
- Email: alert_4c@aibili.pt
- Phone: 239480137
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.