NCT07417410 Analysis of DR Progression to Identify Risks and Need for Treatment
| NCT ID | NCT07417410 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Association for Innovation and Biomedical Research on Light and Image |
| Condition | Diabetic Retinopathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-11-03 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2025-11-03 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Luís Mendes, PhD
STUDY DIRECTOR
Association for Innovation and Biomedical Research on Light and Image
Frequently Asked Questions
Who can join the NCT07417410 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 90 Years, studying Diabetic Retinopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07417410 currently recruiting?
Yes, NCT07417410 is actively recruiting participants. Contact the research team at alert_4c@aibili.pt for enrollment information.
Where is the NCT07417410 trial being conducted?
This trial is being conducted at Portugal, Portugal.
Who is sponsoring the NCT07417410 clinical trial?
NCT07417410 is sponsored by Association for Innovation and Biomedical Research on Light and Image. The principal investigator is Luís Mendes, PhD at Association for Innovation and Biomedical Research on Light and Image. The trial plans to enroll 1,000 participants.