RECRUITINGOBSERVATIONAL

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

About This Trial

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).

Who May Be Eligible (Plain English)

Inclusion Criteria - Longitudinal study (patients): 1. Participant is willing and able to give willing to sign a consent form for participation in the trial. 2. Male or Female, aged 40 - 80 years; 3. In good general health as evidenced by medical history or diagnosed with type 2 diabetes for less than 10 years without clinical signs of retinopathy and other diabetic complications; 4. HbA1c level 7% or greater; Inclusion Criteria - Longitudinal study (healthy controls) 1. Participant is willing and able to give willing to sign a consent form for participation in the trial; 2. Male or Female, aged 40 - 80 years; 3. In good general health as evidenced by medical history without diagnosis of type 2 diabetes; Inclusion Criteria - Cross-sectional study 1. Participant is willing and able to give willing to sign a consent form for participation in the trial; 2. Male or Female, aged 40 - 80 years; 3. Patient with a diagnosis of type 2 diabetes for longer than 20 years in the absence or presence of clinical signs of retinopathy and other diabetic complications; 4. HbA1c level 7% or greater. Exclusion Criteria (longitudinal study and cross-sectional study) An individual who meets any of the following criteria will be excluded from participation in this study: 1. retinal or systemic diseases other than diabetes; 2. hypertension (BP values greater than 140/90 mm Hg); 3. anemia (hematocrit less than 35%); 4. smoking; 5. laser treatment and pregnancy Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria - Longitudinal study (patients): 1. Participant is willing and able to give informed consent for participation in the trial. 2. Male or Female, aged 40 - 80 years; 3. In good general health as evidenced by medical history or diagnosed with type 2 diabetes for less than 10 years without clinical signs of retinopathy and other diabetic complications; 4. HbA1c level 7% or greater; Inclusion Criteria - Longitudinal study (healthy controls) 1. Participant is willing and able to give informed consent for participation in the trial; 2. Male or Female, aged 40 - 80 years; 3. In good general health as evidenced by medical history without diagnosis of type 2 diabetes; Inclusion Criteria - Cross-sectional study 1. Participant is willing and able to give informed consent for participation in the trial; 2. Male or Female, aged 40 - 80 years; 3. Patient with a diagnosis of type 2 diabetes for longer than 20 years in the absence or presence of clinical signs of retinopathy and other diabetic complications; 4. HbA1c level 7% or greater. Exclusion Criteria (longitudinal study and cross-sectional study) An individual who meets any of the following criteria will be excluded from participation in this study: 1. retinal or systemic diseases other than diabetes; 2. hypertension (BP values greater than 140/90 mm Hg); 3. anemia (hematocrit less than 35%); 4. smoking; 5. laser treatment and pregnancy

Treatments Being Tested

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.

Locations (2)

Irccs Ospedale San Raffaele

Milan, Italy/milan, Italy

IRCCS Ospedale San Raffaele _O.U. Ophthalmology

Milan, Italy, Italy