Ignite Creation Date:
2024-05-05 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 9:55 AM
Study NCT ID:
NCT00763802
Status:
COMPLETED
Last Update Posted:
2014-04-07
First Post:
2008-09-30
Brief Title:
Validation of a Predictive Model to Estimate the Risk of Conversion to Clinically Significant Macular Edema andor Vision Loss in Mild Nonproliferative Diabetic Retinopathy in Diabetes Type 2
Sponsor:
Association for Innovation and Biomedical Research on Light and Image
Organization:
Association for Innovation and Biomedical Research on Light and Image
Study Overview
Official Title:
Validation of a Predictive Model to Estimate the Risk of Conversion to Clinically Significant Macular Edema andor Vision Loss in Mild Nonproliferative Diabetic Retinopathy in Diabetes Type 2
Status:
COMPLETED
Status Verified Date:
2014-04
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:
CPM
Brief Summary:
This project aims to validate a predictive model of diabetic retinopathy progression to clinically significant macular edema CSME needing photocoagulation andor vision loss The Coimbra Predictive Model CPM based on retinal thickness microaneurysms number HbA1C and LDL levels established on a set of 52 diabetic patients will be tested on a population of 400 patientseyes to be enrolled into the study These patients will perform 2 visits at 6-month interval V0 and V6 to classify each patient into one of the 3 previously established phenotypes Two years after V24 patients will be reexamined The occurrence of end-points achieved by the patients are expected to validate our predictive model
Detailed Description:
None
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