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

This study is enrolling participants by invitation only.
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: November 12, 2010
Last verified: October 2010
History of Changes

October 26, 2010
November 12, 2010
March 2010
June 2011   (final data collection date for primary outcome measure)
Phenotypes of Diabetic Retinopathy progression. [ Time Frame: June 2011 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01228981 on ClinicalTrials.gov Archive Site
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Observational Study to Assess Genotypes/Phenotypes Correlations in Type-2 Diabetic Retinopathy
Observational Study to Assess Genotypes/Phenotypes Correlations in Type-2 Diabetic Retinopathy

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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).
Type-2 Diabetic Retinopathy
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Type-2 Diabetic Retinopathy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
400
March 2013
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Portugal
 
NCT01228981
PTDC/SAU-OSM/103226/2008
No
CEC, AIBILI
Association for Innovation and Biomedical Research on Light and Image
  • BIOCANT - Associação de Transferência de Tecnologia
  • Faculdade de Medicina - Universidade de Coimbra
Principal Investigator: Conceição Lobo, MD PhD Association for Innovation and Biomedical Research on Light and Image
Association for Innovation and Biomedical Research on Light and Image
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP