RecruitingNCT06582472

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

Sponsor

IRCCS Ospedale San Raffaele

Enrollment

180 participants

Start Date

Sep 29, 2023

Study Type

OBSERVATIONAL

Conditions

Diabetic Retinopathy Associated With Type 2 Diabetes Mellitus Diabetic Retinopathy

Summary

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).

Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether nerve cell damage in the retina (the light-sensitive layer at the back of the eye) appears before visible signs of diabetic eye disease develop. Retinal nerve degeneration may be an early warning sign that could help doctors intervene sooner. The study also tests potential treatments. **You may be eligible if...** - You are between 40 and 80 years old - You have type 2 diabetes diagnosed less than 10 years ago, with no current visible signs of eye damage - Your blood sugar control is poor (HbA1c of 7% or higher) - You are in good general health aside from diabetes **You may NOT be eligible if...** - You already have visible diabetic retinopathy or other diabetic complications - You have eye conditions that would prevent accurate retinal imaging (e.g., cataracts, glaucoma) - You have had eye surgery recently 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREOphthalmological examination including imaging assessments

Ophthalmological examination including imaging assessments (SD-OCT, Spectral Domain Optical Coherence Tomography, a procedure to study and quantify possible retinal neurodegeneration and OCT-A, Optical coherence tomography angiography, a procedure to study and quantify possible retinal vascular abnormalities)

PROCEDUREconfocal analysis of cornea

Confocal analysis of cornea: a procedure to study and quantify possible corneal nerve degeneration as a marker of involvement of diabetic neuropathy

PROCEDUREDynamic Vessel Analyzer (DVA)

Dynamic Vessel Analyzer (DVA), a device that measures the response of retinal arteries and veins to a standardized stimulus (flickering light) allowing direct quantification of the inflammatory status of the retinal vasculature

PROCEDUREtear sampling collection

Collect and analyze tear samples to identify biomarkers in tears and at the endothelium of the ocular surface through impression conjunctival cytology and the quantitative/qualitative analysis of pro-inflammatory cytokines

PROCEDUREblood sampling collection

collection and analysis of blood samples to identify diabetic retinopathy biomarkers and early abnormalities of the vascular retinal system.