RecruitingNCT07458516

Longitudinal Observational Study of Diabetic Retinopathy Progression in Type 2 Diabetes Patients

IMaging Pre-PrOlifeRative sTAge of Diabetic retiNopaThy to Guarantee Timely Treatment - IMPORTANT


Sponsor

Association for Innovation and Biomedical Research on Light and Image

Enrollment

100 participants

Start Date

Nov 24, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this clinical study is to explore imaging, functional and systemic biomarkers of diabetic retinopathy (DR) progression, in Type 2 Diabetes (T2D) patients with moderate to severe non-proliferative diabetic retinopathy (NPDR) and mild proliferative diabetic retinopathy (PDR) using state of the art methodologies, commonly applied in clinical practice, over a period of two years. This study will provide longitudinal data to better understand retinal changes in moderate to severe diabetic retinopathy and early proliferative diabetic retinopathy and help guide timely interventions to prevent vision loss.


Eligibility

Min Age: 35 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study follows patients with type 2 diabetes over time to track whether and how quickly diabetic retinopathy—damage to the blood vessels in the back of the eye caused by high blood sugar—worsens. The goal is to better understand which patients are at highest risk of vision loss so doctors can intervene earlier. **You may be eligible if...** - You are between 35 and 80 years old and have type 2 diabetes - You have non-proliferative diabetic retinopathy or mild early proliferative disease in your eye (but no severe complications yet) - Your vision is at least 20/40 - Your retinal specialist believes treatment can safely be delayed for at least 6 months **You may NOT be eligible if...** - You have severe fluid or swelling in the center of the retina (central subfield thickness above 400 µm) - You have significant growth of new blood vessels in the eye - You have uncontrolled glaucoma or other significant eye conditions - You have had prior pan-retinal laser or injections into the eye - You have had eye surgery within 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

AIBILI-CEC (AIBILI-Clinical Trial Centre)

Coimbra, Portugal

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NCT07458516


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