Validation of a Predictive Model to Estimate the Risk of Conversion to Clinically Significant Macular Edema and/or Vision Loss in Mild Nonproliferative Diabetic Retinopathy in Diabetes Type 2 (CPM)
This project aims to validate a predictive model of diabetic retinopathy progression to clinically significant macular edema (CSME) needing photocoagulation and/or 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 patients/eyes 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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Validation of a Predictive Model to Estimate the Risk of Conversion to Clinically Significant Macular Edema and/or Vision Loss in Mild Nonproliferative Diabetic Retinopathy in Diabetes Type 2|
- CSME needing Photocoagulation [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Vision Loss [ Time Frame: 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Study Completion Date:||May 2011|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Type 2 diabetic patients with Mild non-prolipherative retinopathy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00763802
|Coimbra, Portugal, 3000-548|
|Principal Investigator:||José G Cunha-Vaz, MD, PhD||Association for Innovation and Biomedical Research on Light and Image|