Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00411333
Status:
COMPLETED
Last Update Posted:
2010-11-11
First Post:
2006-12-13
Brief Title:
Vascular Remodeling and the Effects of Angiogenic Inhibition in Diabetic Retinopathy
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
Vascular Remodeling and the Effects of Angiogenic Inhibition in Diabetic Retinopathy
Status:
COMPLETED
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The retinal vasculature changes dramatically in patients with diabetic retinopathy especially between non-proliferative and proliferative disease The retinal vasculature can be imaged and quantified using special dyes This study will test whether the pattern of the retinal vasculature changes in patients with different levels of diabetic retinopathy can be quantified using computerized image analysis In addition the study will evaluate whether new drugs to treat diabetic retinopathy will be able to reverse these vascular changes
Detailed Description:
In this study we are studying whether vascular density decreases during diabetic retinopathy prior to the pathological neovascularization seen in proliferative disease that results in blindness in more than 50 percent of patients and whether the adverse early vascular remodeling and neovascularization can be reversed by anti-angiogenic therapeutics We have shown that vascular density decreases during early stages of diabetic retinopathy prior to the pathological neovascularization that defines proliferative retinopathy and that this change may be reversible with new anti-angiogenic therapeutics To test this hypothesis we will determine 1 how blood vessels remodel and whether vascular density truly decreases during diabetic retinopathy and 2 how the anti-angiogenic steroid triamcinolone acetonide affects vascular density and pattern during human diabetic retinopathy and in our experimental model the avian CAM model
Twenty patients n 20 for each of the 4 NPDR stages will be enrolled In addition a control group of 20 normal subjects will be recruited from the same clinical practice that do not have diabetes and no evidence of any vascular disease for a total of 100 patients in the clinical trial
Twenty patients n 20 for each of the 4 NPDR stages will be enrolled In addition a control group of 20 normal subjects will be recruited from the same clinical practice that do not have diabetes and no evidence of any vascular disease for a total of 100 patients in the clinical trial
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