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

Type-2 Diabetic Retinopathy Clinical Trial

— CEC120  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01228981
• Other study ID #: PTDC/SAU-OSM/103226/2008
• Status: Completed
• Phase: N/A
• First received: October 26, 2010
• Last updated: April 22, 2016
• Start date: March 2010
• Est. completion date: March 2013

Study information

• Verified date: April 2016
• Source: Association for Innovation and Biomedical Research on Light and Image
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: AIBILI-Comissão de Ética para a Saúde
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 2013
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases
• Type-2 Diabetic Retinopathy

Locations

Country	Name	City	State
Portugal	AIBILI - Clinical Trials Center	Coimbra

Sponsors (2)

Lead Sponsor	Collaborator
Association for Innovation and Biomedical Research on Light and Image	University of Coimbra

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phenotypes of Diabetic Retinopathy progression.		June 2011	No

External Links

•   Link