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

This study has been completed.
Sponsor:
Information provided by:
European Vision Institute Clinical Research Network
ClinicalTrials.gov Identifier:
NCT01145599
First received: June 15, 2010
Last updated: November 12, 2013
Last verified: November 2013

June 15, 2010
November 12, 2013
September 2010
October 2013   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01145599 on ClinicalTrials.gov Archive Site
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.

Same as current
Not Provided
Not Provided
 
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

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

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Type-2 diabetes, NPDR

  • Type 2 Diabetes
  • Non Proliferative Diabetic Retinopathy
Not Provided
Type-2 diabetes, NPDR
Type-2 diabetic patients with NPDR.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
Not Provided
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Diabetes type 2 according to 1985 WHO criteria
  2. Age between 35 and 75 years
  3. Mild non-proliferative diabetic retinopathy (levels 20 or 35, based on the ETDRS criteria) - 7 fields color fundus photography
  4. Presence of at least 1 microaneurysm in the central 3000 micr. in diameter area (corresponding to 2 DA) - Field 2
  5. Best Corrected Visual Acuity >= 75 letters (>= 20 /32)
  6. Refraction with a spherical equivalent less than 5 Dp
  7. Informed consent

Exclusion Criteria:

  1. Cataract or other eye disease that may interfere with fundus examinations
  2. Glaucoma
  3. Any eye surgery within a period of 6-months
  4. Other retinal vascular disease
  5. Previous laser therapy
  6. Dilatation of the pupil < 5 mm
Both
35 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Portugal
 
NCT01145599
ECR-RET-2010-02
No
José Cunha-Vaz, MD PhD, AIBILI
European Vision Institute Clinical Research Network
Not Provided
Study Chair: José Cunha-Vaz, MD PhD Association for Innovation and Biomedical Research on Light and Image
European Vision Institute Clinical Research Network
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP