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Observational Study to Assess Genotypes/Phenotypes Correlations in Type-2 Diabetic Retinopathy (CEC120)
This study has been completed.
Sponsor:
Association for Innovation and Biomedical Research on Light and Image
Collaborator:
University of Coimbra
Information provided by (Responsible Party):
Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier:
NCT01228981
First received: October 26, 2010
Last updated: April 22, 2016
Last verified: April 2016
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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 ]
| 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 (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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01228981
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
University of Coimbra
Investigators
| Principal Investigator: | Conceição Lobo, MD PhD | Association for Innovation and Biomedical Research on Light and Image |
More Information
Additional Information:
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 |
| Study First Received: | October 26, 2010 |
| Last Updated: | April 22, 2016 |
Additional relevant MeSH terms:
|
Retinal Diseases Diabetic Retinopathy Eye Diseases Diabetic Angiopathies Vascular Diseases |
Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 23, 2017