Actively Recruiting

Age: 40Years - 80Years
All Genders
Healthy Volunteers
NCT06582472

Early Retinal Neurodegeneration As Risk Factor, Biomarker and Pharmacological Target of Diabetic Retinopathy

Led by IRCCS Ospedale San Raffaele · Updated on 2024-09-03

180

Participants Needed

2

Research Sites

85 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Despite the evidence that diabetic retinopathy (DR) remains the first cause of blindness among the working-age population, it lacks a specific preventive treatment. This is because early mechanisms leading to the development of DR have been, until recently, unknown. Recent studies have suggested that the early stages of DR could be preceded by neuronal abnormalities, in particular retinal ganglion cell death, coupled with widespread retinal inflammation. According to these studies, endothelial dysfunction and the development of microaneurysms, the classic hallmarks of DR, could be the consequence of these early abnormalities. This project will aim to verify whether neurodegeneration could represent at the same time: 1) a risk factor for subsequent development of DR (this will be investigated through a follow-up study in type 2 diabetic patients free of diabetic retinopathy). 2) a biomarker of the complication (if so, patients with long-standing diabetes in the absence of retinopathy should show no signs of neurodegeneration).

CONDITIONS

Official Title

Early Retinal Neurodegeneration As Risk Factor, Biomarker and Pharmacological Target of Diabetic Retinopathy

Who Can Participate

Age: 40Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing and able to give informed consent
  • Male or Female aged 40 to 80 years
  • For longitudinal study patients: diagnosed with type 2 diabetes for less than 10 years without diabetic retinopathy or other diabetic complications
  • HbA1c level 7% or greater (patients)
  • For healthy controls: good general health without a diagnosis of type 2 diabetes
  • For cross-sectional study: diagnosed with type 2 diabetes for over 20 years, with or without diabetic retinopathy
  • HbA1c level 7% or greater (cross-sectional study)
Not Eligible

You will not qualify if you...

  • Retinal or systemic diseases other than diabetes
  • Hypertension with blood pressure greater than 140/90 mm Hg
  • Anemia with hematocrit less than 35%
  • Current smoking
  • Prior laser treatment
  • Pregnancy

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Irccs Ospedale San Raffaele

Milan, Italy/milan, Italy, 20132

Actively Recruiting

2

IRCCS Ospedale San Raffaele _O.U. Ophthalmology

Milan, Italy, Italy, 20123

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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