NCT06582472 Early Retinal Neurodegeneration As Risk Factor, Biomarker and Pharmacological Target of Diabetic Retinopathy

Eligibility & Interventions

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 180 participants in total. It began in 2023-09-29 with a primary completion date of 2025-05-19.

Brief 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 Criteria

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

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