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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: t
View:

• Participant is willing and able to give informed consent for participation in the trial.

• Male or Female, aged 40 - 80 years;

• 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;

• HbA1c level 7% or greater;

• Participant is willing and able to give informed consent for participation in the trial;

• Male or Female, aged 40 - 80 years;

• In good general health as evidenced by medical history without diagnosis of type 2 diabetes;

• Participant is willing and able to give informed consent for participation in the trial;

• Male or Female, aged 40 - 80 years;

• 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;

• HbA1c level 7% or greater.

Locations
Other Locations
Italy
Irccs Ospedale San Raffaele
RECRUITING
Milan
IRCCS Ospedale San Raffaele _O.U. Ophthalmology
RECRUITING
Milan
Time Frame
Start Date: 2023-09-29
Estimated Completion Date: 2025-05-19
Participants
Target number of participants: 180
Treatments
cohort 1 (longitudinal study)
This group will include patients affected by type 2 diabetes for less than 10 years and without signs of diabetic retinopathy, nephropathy, and neuropathy.
cohort 2 (longitudinal study)
healthy controls: subjects in good general health as evidenced by medical history without diagnosis of type 2 diabetes
cohort 1 (cross sectional study)
Patients with a diagnosis of type 2 diabetes for longer than 20 years without clinical signs of retinopathy and other diabetic complications
cohort 2 (cross sectional study)
Patients with a diagnosis of type 2 diabetes for longer than 20 years with clinical signs of retinopathy and other diabetic complications
Sponsors
Leads: IRCCS Ospedale San Raffaele

This content was sourced from clinicaltrials.gov