Actively Recruiting

Age: 35Years - 90Years
All Genders
ID07417410

Analysis of Diabetic Retinopathy Progression to Identify Risks and Need for Treatment

Led by Association for Innovation and Biomedical Research on Light and Image · Updated on 2026-03-02

1000

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

A

Association for Innovation and Biomedical Research on Light and Image

Lead Sponsor

F

Fundação para a Ciência e a Tecnologia

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying diabetic retinopathy (DR), a common eye condition in adults with type 2 diabetes, to understand how changes in the eye's blood vessels and structure may predict worsening of DR and related heart problems. This observational study includes about 1,000 adults aged 35 to 90 years and aims to explore the link between eye changes and cardiovascular complications over one year. It also uses past medical and imaging data from previous visits within the last 1 to 5 years to enhance findings. The study focuses on analyzing central and peripheral retinal lesions through advanced imaging and clinical data to see how they relate to DR progression and cardiovascular risks. The data collected will help build a high-quality database to support artificial intelligence models predicting DR severity and cardiovascular outcomes. No treatments are given; the study observes existing health information and imaging results. Participants will be monitored over 12 months with eye imaging, clinical evaluations, and collection of cardiovascular and diabetes-related data. Researchers will measure changes in DR staging, visual acuity, and occurrences of major heart events. Additional assessments include detailed retinal features, blood sugar levels, and blood pressure correlations. The study aims to improve understanding of DR and cardiovascular risks in people with type 2 diabetes, lasting from initial data collection through one year of follow-up.

CONDITIONS

Brief Title

Analysis of DR Progression to Identify Risks and Need for Treatment

Who Can Participate

Age: 35Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with type 2 diabetes according to the 1985 WHO criteria
  • Age between 35 and 90 years
  • Have a documented follow-up of 1 to 5 years with at least one clinical visit if retrospective
  • Have diabetic retinopathy, at least one cardiovascular risk factor, or cardiovascular complications at baseline if referenced patient
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Previous laser photocoagulation or intravitreal injections (consider corticosteroids)
  • Clinically significant macular edema with vision loss or needing immediate treatment
  • Proliferative diabetic retinopathy
  • Any ocular surgery within the last 3 months
  • Receiving renal replacement therapy such as hemodialysis or peritoneal dialysis
  • Severe systemic illness as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Baseline assessment

Participants undergo retinal imaging and clinical assessments to evaluate diabetic retinopathy progression and cardiovascular risk factors.

1 visit (in-person)

Long-term Monitoring

Duration - 12 months

Participants are monitored for changes in diabetic retinopathy staging and cardiovascular events over time.

Follow-up assessments during the 12-month period

Trial Site Locations

Total: 1 location

1

AIBILI-Clinical Trial Centre

Portugal, Coimbra District, Portugal, 3000-548

Actively Recruiting

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Research Team

J

Joana F Tavares, PhD

L

Liliana C Soares, MsC

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Frequently Asked Questions

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Published Research Related To This Trial

Retinopathy Phenotypes in Type 2 Diabetes with Different Risks for Macular Edema and Proliferative Retinopathy.

Ines P Marques, Maria H Madeira, Ana L Messias...

https://pubmed.ncbi.nlm.nih.gov/32408522

Subclassification of preproliferative diabetic retinopathy and glycemic control: relationship between mean hemoglobin A1C value and development of proliferative diabetic retinopathy.

Y Sato, Z Lee, Y Hayashi

https://pubmed.ncbi.nlm.nih.gov/11583677

Peripheral Lesions Identified on Ultrawide Field Imaging Predict Increased Risk of Diabetic Retinopathy Progression over 4 Years.

Paolo S Silva, Jerry D Cavallerano, Nour Maya N Haddad...

https://pubmed.ncbi.nlm.nih.gov/25704318