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

NCT ID: NCT01228981

Last Updated: 2016-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type-2 Diabetic Retinopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Type-2 Diabetic Retinopathy

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Coimbra

OTHER

Sponsor Role collaborator

Association for Innovation and Biomedical Research on Light and Image

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Conceição Lobo, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Association for Innovation and Biomedical Research on Light and Image

Locations

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AIBILI - Clinical Trials Center

Coimbra, Coimbra District, Portugal

Site Status

Countries

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Portugal

References

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Cunha-Vaz J, Ribeiro L, Lobo C. Phenotypes and biomarkers of diabetic retinopathy. Prog Retin Eye Res. 2014 Jul;41:90-111. doi: 10.1016/j.preteyeres.2014.03.003. Epub 2014 Mar 26.

Reference Type DERIVED
PMID: 24680929 (View on PubMed)

Related Links

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Other Identifiers

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PTDC/SAU-OSM/103226/2008

Identifier Type: -

Identifier Source: org_study_id

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