NCT00763802

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 400 (actual)
• Sponsor: Association for Innovation and Biomedical Research on Light and Image · Academic / Other
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Diabetic Retinopathy

Timeline

• Start date: 2007-09-01
• Primary completion: 2010-09-01
• Completion: 2011-05-01
• First posted: 2008-10-01
• Last updated: 2014-04-07

Locations

1 site across 1 country: Portugal