NCT01145599

Identifying Progression of Retinal Disease in Eyes With NPDR in Diabetes Type 2 Using Non-invasive Procedures

Identifying Progression of Retinal Disease in Eyes With Non Proliferative Diabetic Retinopathy in Diabetes Type 2 Using Non-invasive Procedures

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 374 (actual)
• Sponsor: European Vision Institute Clinical Research Network · Network
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to identify eyes that show worsening and disease progression (progressor phenotypes).

Detailed description

To identify "progressors" in retinal vascular disease and central retinal edema in type 2 diabetic patients with early NPDR, based on retinal disease progression from baseline to the 12-month visit, assessed by the following biomarkers: * Microaneurysms turnover (MA formation rate over or equal to 2, i.e. number of new MA from baseline to the 12-month visit) computed from color fundus photographs using the RetmarkerDR software; and * Retinal thickness increase in eyes with retinal thickening (Increase in retinal thickness above normal range) in the central subfield, the inner ring and/or the outer ring Constantly Present, Present or Absent (as measured by OCT and considering the macula thickness normative data.

Conditions

• Type 2 Diabetes
• Non Proliferative Diabetic Retinopathy

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-10-01
• First posted: 2010-06-16
• Last updated: 2015-02-11

Locations

1 site across 1 country: Portugal