Actively Recruiting
Early Retinal Neurodegeneration As Risk Factor, Biomarker and Pharmacological Target of Diabetic Retinopathy
Led by IRCCS Ospedale San Raffaele · Updated on 2024-09-03
180
Participants Needed
2
Research Sites
85 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Early Retinal Neurodegeneration As Risk Factor, Biomarker and Pharmacological Target of Diabetic Retinopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to give informed consent
- Male or Female aged 40 to 80 years
- For longitudinal study patients: diagnosed with type 2 diabetes for less than 10 years without diabetic retinopathy or other diabetic complications
- HbA1c level 7% or greater (patients)
- For healthy controls: good general health without a diagnosis of type 2 diabetes
- For cross-sectional study: diagnosed with type 2 diabetes for over 20 years, with or without diabetic retinopathy
- HbA1c level 7% or greater (cross-sectional study)
You will not qualify if you...
- Retinal or systemic diseases other than diabetes
- Hypertension with blood pressure greater than 140/90 mm Hg
- Anemia with hematocrit less than 35%
- Current smoking
- Prior laser treatment
- Pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Irccs Ospedale San Raffaele
Milan, Italy/milan, Italy, 20132
Actively Recruiting
2
IRCCS Ospedale San Raffaele _O.U. Ophthalmology
Milan, Italy, Italy, 20123
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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