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

RecruitingOBSERVATIONAL
Enrollment

180

Participants

Timeline

Start Date

September 29, 2023

Primary Completion Date

May 19, 2025

Study Completion Date

May 19, 2025

Conditions
Diabetic RetinopathyDiabetic Retinopathy Associated with Type 2 Diabetes Mellitus
Interventions
PROCEDURE

Ophthalmological 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)

PROCEDURE

confocal 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

PROCEDURE

Dynamic 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

PROCEDURE

tear 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

PROCEDURE

blood sampling collection

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

Trial Locations (2)

20123

RECRUITING

IRCCS Ospedale San Raffaele _O.U. Ophthalmology, Milan

20132

RECRUITING

Irccs Ospedale San Raffaele, Milan

All Listed Sponsors
lead

IRCCS Ospedale San Raffaele

OTHER