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
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: 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 by Association for Innovation and Biomedical Research on Light and Image

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Endocrine System Diseases
Eye Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014