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Completed

NCT Number: NCT01228981

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AIBILI - Clinical Trials Center

Coimbra, Coimbra District, 3000-548, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Phenotypes of Diabetic Retinopathy progression.

    Time frame: June 2011

Sponsors and collaborators

Lead sponsor

Association for Innovation and Biomedical Research on Light and Image

Other

Collaborators

  • University of Coimbra

Registry information

Acronym: CEC120

Important dates

Study start
2010
Primary completion
2011
Study completion
2013
First posted
Oct 27, 2010
Registry last updated
Apr 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.