Identifying Progression of Retinal Disease in Eyes With NPDR in Diabetes Type 2 Using Non-invasive Procedures
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01145599|
Recruitment Status : Completed
First Posted : June 16, 2010
Last Update Posted : February 11, 2015
|Condition or disease|
|Type 2 Diabetes Non Proliferative Diabetic Retinopathy|
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.
|Study Type :||Observational|
|Actual Enrollment :||374 participants|
|Official Title:||Identifying Progression of Retinal Disease in Eyes With Non Proliferative Diabetic Retinopathy in Diabetes Type 2 Using Non-invasive Procedures|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||October 2013|
Type-2 diabetes, NPDR
Type-2 diabetic patients with NPDR.
- Identify "progressors" [ Time Frame: 12 months ]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 ]
To identify correlations between "progressors" and the different study outcomes.
To explore the parameters, and to identify highly predictive outcomes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|