Observational Study to Assess Genotypes/Phenotypes Correlations in Type-2 Diabetic Retinopathy

This study has been completed.
Sponsor:
Collaborators:
BIOCANT - Associação de Transferência de Tecnologia
Faculdade de Medicina - Universidade de Coimbra
Information provided by:
Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier:
NCT01228981
First received: October 26, 2010
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to characterize type 2 diabetic patients with initial alterations of diabetic retinopathy (DR) based on 3 different phenotypes previously identified and different patterns of progression in order to correlate this data with genetic information.


Condition
Type-2 Diabetic Retinopathy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study to Assess Genotypes/Phenotypes Correlations in Type-2 Diabetic Retinopathy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Phenotypes of Diabetic Retinopathy progression. [ Time Frame: June 2011 ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: March 2010
Study Completion Date: March 2013
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Type-2 Diabetic Retinopathy

Detailed Description:

This study aims to to characterize type 2 diabetic patients with initial alterations of diabetic retinopathy (DR) based on three different phenotypes previously identified and different patterns of progression [Lobo, 2004] in order to correlate this data with genetic information (based on a list of candidate genes previously identified as being involved in DR).

The results of this study will be used exclusively for scientific purposes.

  Eligibility

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

Type-2 diabetic subjects in the early stages of non-proliferative retinopathy (level 30 to 35 ETDRS) included in the clinical trial "Validation of a predictive model to estimate the risk of conversion to clinically significant macular edema and/or vision loss in mild nonproliferative diabetic retinopathy in diabetes type 2" (Protocol number: PTDC/SAU-OSM/72635/2006; ongoing at AIBILI Clinical Trial Center).

Criteria

Inclusion Criteria:

  • Type-2 diabetic subjects form the PTDC/SAU-OSM/72635/2006 clinical trial (early stages of non-proliferative retinopathy - level 30 to 35 ETDRS;. females or males; age over 18 years) with a signed Informed Consent for this study.

Exclusion Criteria:

  • Cataract or other eye disease that may interfere with fundus examinations; Vitreous syneresis or posterior vitreous detachment; and Dilatation of the pupil < 5 mm.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01228981

Locations
Portugal
AIBILI - Clinical Trials Center
Coimbra, Portugal, 3000-548
Sponsors and Collaborators
Association for Innovation and Biomedical Research on Light and Image
BIOCANT - Associação de Transferência de Tecnologia
Faculdade de Medicina - Universidade de Coimbra
Investigators
Principal Investigator: Conceição Lobo, MD PhD Association for Innovation and Biomedical Research on Light and Image
  More Information

Additional Information:
No publications provided

Responsible Party: CEC, AIBILI
ClinicalTrials.gov Identifier: NCT01228981     History of Changes
Other Study ID Numbers: PTDC/SAU-OSM/103226/2008
Study First Received: October 26, 2010
Last Updated: April 4, 2014
Health Authority: Portugal: AIBILI-Comissão de Ética para a Saúde

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 17, 2014