Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582472
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Early Retinal Neurodegeneration As Risk Factor Biomarker and Pharmacological Target of Diabetic Retinopathy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Early Retinal Neurodegeneration As Risk Factor Biomarker and Pharmacological Target of Diabetic Retinopathy
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
2022-12376008
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
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
Detailed Description:
The project is centered on a clinical study aimed to clarify whether early diabetes-driven neurodegeneration something that has been demonstrated by several seminal studies is related possibly causative to the subsequent development of DR a concept that is presently far from being confirmed but that in case would probably pave the way to identify for the first time a treatment for this diabetic complication
This project includes two substudies
LONGITUDINAL STUDY the aim is to verify whether the presence of retinal neurodegeneration in type 2 diabetic patients without DR increases the risk of subsequent development of retinal microaneurisms the classic first vascular sign of DR will enroll 90 individuals affected by type 2 diabetes and 30 healthy controls All the subjects will be recruited during the first 6 months of the study and followed for 24 months baseline month 6 month 12 month 18 and month 24
CROSS-SECTIONAL STUDY the aim is to verify the clinical evidence of retinal neurodegeneration in patients with type 2 diabetes diagnosed over 20 years and with overt diabetic retinopathy compared to patients with type 2 diabetes diagnosed for over 20 years but no signs of diabetic retinopathy Will be enrolled 30 individuals affected by type 2 diabetes with a duration of disease longer than 20 years and no clinical signs of DR and 30 individuals affected by type 2 diabetes with a duration of disease longer than 20 years and DR of any stage All the subjects will be recruited during the first 6 months of the study and subjected to only one visit to the site
This project includes two substudies
LONGITUDINAL STUDY the aim is to verify whether the presence of retinal neurodegeneration in type 2 diabetic patients without DR increases the risk of subsequent development of retinal microaneurisms the classic first vascular sign of DR will enroll 90 individuals affected by type 2 diabetes and 30 healthy controls All the subjects will be recruited during the first 6 months of the study and followed for 24 months baseline month 6 month 12 month 18 and month 24
CROSS-SECTIONAL STUDY the aim is to verify the clinical evidence of retinal neurodegeneration in patients with type 2 diabetes diagnosed over 20 years and with overt diabetic retinopathy compared to patients with type 2 diabetes diagnosed for over 20 years but no signs of diabetic retinopathy Will be enrolled 30 individuals affected by type 2 diabetes with a duration of disease longer than 20 years and no clinical signs of DR and 30 individuals affected by type 2 diabetes with a duration of disease longer than 20 years and DR of any stage All the subjects will be recruited during the first 6 months of the study and subjected to only one visit to the site
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None