Finding eye changes that signal diabetic retinopathy progression and need for treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• AIBILI-Clinical Trial Centre
  Portugal, Coimbra District, Portugal Recruiting

Study contacts

• Study coordinator: Joana F Tavares, PhD
• Email: alert_4c@aibili.pt
• Phone: 239480137

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• MK-8748 vs. aflibercept for diabetic macular edema

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• Surabgene Lomparvovec in the Suprachoroidal Space for Diabetic Retinopathy

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  Recruiting at 40 sites Phase 2/3 AbbVie · Mesa, Arizona and 39 other locations · NCT07592273

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.