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
  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:


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
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: November 12, 2013
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 July 29, 2014