Phenotyping Diabetic Retinopathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier:
NCT00840541
First received: February 9, 2009
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to validate and characterize phenotypes of diabetic retinopathy (DR) progression based on available clinical data (demographic, systemic and ophthalmic data).


Condition
Diabetic Retinopathy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Observational Study of Type-2 Diabetic Subjects to Validate Diabetic Retinopathy Phenotypes

Resource links provided by NLM:


Further study details as provided by Association for Innovation and Biomedical Research on Light and Image:

Primary Outcome Measures:
  • CSME [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: January 2009
Study Completion Date: January 2012
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
DR
Type-2 diabetic subjects diagnosed with diabetic retinopathy (DR).

Detailed Description:

This study aims to validate and characterize phenotypes of diabetic retinopathy (DR) progression using ophthalmic and systemic data from type-2 diabetic subjects followed at the AIBILI Clinical Trial Center in the last 10 years.

Macular Edema (ME) development during the study period, mainly Clinically Significant ME (CSME) needing treatment, will be the primary indicator for DR progression. CSME will be considered as the primary end-point and will be used to identify phenotypes (and risk markers) of DR progression.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Type-2 diabetic subjects diagnosed with DR, followed regularly by their ophthalmologist at the AIBILI Clinical Trial Center, with a previous follow-up in which systemic data and ophthalmological examinations were performed regularly.

Criteria

Inclusion Criteria:

  • Diagnosis of DR.
  • Females or Males;
  • Age over 18 years;
  • Signed Informed Consent;
  • Previous follow-up with regular systemic and ophthalmic assessments.

Exclusion Criteria:

  • Cataract or other eye disease that may interfere with fundus examinations;
  • Vitreous syneresis or posterior vitreous detachment;
  • Dilatation of the pupil < 5 mm.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00840541

Locations
Portugal
AIBILI - Clinical Trial Center
Coimbra, Portugal, 3000-548
Sponsors and Collaborators
Association for Innovation and Biomedical Research on Light and Image
Investigators
Principal Investigator: José Cunha-Vaz, MD PhD Association for Innovation and Biomedical Research on Light and Image
  More Information

Additional Information:
Publications:
Responsible Party: Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier: NCT00840541     History of Changes
Other Study ID Numbers: CNTM018A
Study First Received: February 9, 2009
Last Updated: April 4, 2014
Health Authority: Portugal: Health Ethic Committee

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014