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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
European Vision Institute Clinical Research Network
ClinicalTrials.gov Identifier:
NCT01145599
First received: June 15, 2010
Last updated: July 18, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition
Type 2 Diabetes
Non Proliferative Diabetic Retinopathy

Study Type: Observational
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by European Vision Institute Clinical Research Network:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.



Estimated Enrollment: 500
Study Start Date: September 2010
Groups/Cohorts
Type-2 diabetes, NPDR
Type-2 diabetic patients with NPDR.

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.
  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Type-2 diabetes, NPDR

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01145599

Locations
Portugal
Centre for Clinical Trials- AIBILI - Association for Innovation and Biomedical Research on Light and Image
Coimbra, Portugal, 3030-548
Sponsors and Collaborators
European Vision Institute Clinical Research Network
Investigators
Study Chair: José Cunha-Vaz, MD PhD Association for Innovation and Biomedical Research on Light and Image
  More Information

No publications provided

Responsible Party: José Cunha-Vaz, MD PhD, AIBILI
ClinicalTrials.gov Identifier: NCT01145599     History of Changes
Other Study ID Numbers: ECR-RET-2010-02
Study First Received: June 15, 2010
Last Updated: July 18, 2012
Health Authority: Europe: European Medicines Agency and European Monitoring Centre for Drugs and Drug Addiction (EMCDDA). According to the study type (observational/interventional) the study will be submitted to each national Competent Authorities.
Portugal: Ethics Committee for Clinical Research

Additional relevant MeSH terms:
Diabetic Retinopathy
Diabetes Mellitus
Diabetes Mellitus, Type 2
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
 Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 16, 2013