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

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).

NCT Number	NCT06582472
Lead Sponsor	IRCCS Ospedale San Raffaele
Conditions	Diabetic Retinopathy, Diabetic Retinopathy Associated with Type 2 Diabetes Mellitus
Enrollment	180 participants
Start Date	2023-09-29
Primary Completion	2025-05-19 (estimated)
Study Completion	2025-05-19 (estimated)
Updated on ClinicalTrials.gov	2024-09-03