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Observational Study to Assess Genotypes/Phenotypes Correlations in Type-2 Diabetic Retinopathy (CEC120)

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ClinicalTrials.gov Identifier: NCT01228981
Recruitment Status : Completed
First Posted : October 27, 2010
Last Update Posted : April 25, 2016
Sponsor:
Collaborator:
University of Coimbra
Information provided by (Responsible Party):
Association for Innovation and Biomedical Research on Light and Image

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease
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.


Study Design
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Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study to Assess Genotypes/Phenotypes Correlations in Type-2 Diabetic Retinopathy
Study Start Date : March 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : March 2013

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Groups and Cohorts
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Group/Cohort
Type-2 Diabetic Retinopathy


Outcome Measures
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Primary Outcome Measures :
  1. Phenotypes of Diabetic Retinopathy progression. [ Time Frame: June 2011 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01228981


Locations
Portugal
AIBILI - Clinical Trials Center
Coimbra, Portugal, 3000-548
Sponsors and Collaborators
Association for Innovation and Biomedical Research on Light and Image
University of Coimbra
Investigators
Principal Investigator: Conceição Lobo, MD PhD Association for Innovation and Biomedical Research on Light and Image
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier: NCT01228981     History of Changes
Other Study ID Numbers: PTDC/SAU-OSM/103226/2008
First Posted: October 27, 2010    Key Record Dates
Last Update Posted: April 25, 2016
Last Verified: April 2016

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