Identifying Progression of Retinal Disease in Eyes With NPDR in Diabetes Type 2 Using Non-invasive Procedures
The purpose of this study is to identify eyes that show worsening and disease progression (progressor phenotypes).
Type 2 Diabetes
Non Proliferative Diabetic Retinopathy
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Identifying Progression of Retinal Disease in Eyes With Non Proliferative Diabetic Retinopathy in Diabetes Type 2 Using Non-invasive Procedures|
- Identify "progressors" [ Time Frame: 12 months ] [ Designated as safety issue: No ]To identify "progressors" in retinal vascular disease and central retinal edema, the following 2 biomarkers will be considered: the MA formation rate (biomarker for the progression of retinal vascular disease) and the presence of retinal thickening in the central subfield and/or the inner ring (biomarker for the presence of retinal edema).
- Identify correlations between "progressors" and study outcomes. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To identify correlations between "progressors" and the different study outcomes.
To explore the parameters, and to identify highly predictive outcomes.
|Study Start Date:||September 2010|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Type-2 diabetes, NPDR
Type-2 diabetic patients with NPDR.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01145599
|Centre for Clinical Trials- AIBILI - Association for Innovation and Biomedical Research on Light and Image|
|Coimbra, Portugal, 3030-548|
|Study Chair:||José Cunha-Vaz, MD PhD||Association for Innovation and Biomedical Research on Light and Image|