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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01228981

Acronym

CEC120

Enrollment

400

Registered

2010-10-27

Start date

2010-03-31

Completion date

2013-03-31

Last updated

2016-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type-2 Diabetic Retinopathy

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Phenotypes of Diabetic Retinopathy progression.	June 2011

Countries

Portugal

Outcome results