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NCT00840541 Clinical Trial

Phenotyping Diabetic Retinopathy

Diabetic Retinopathy Clinical Trial

Official title:
Observational Study of Type-2 Diabetic Subjects to Validate Diabetic Retinopathy Phenotypes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00840541
Other study ID # CNTM018A
Secondary ID
Status Completed
Phase N/A
First received February 9, 2009
Last updated April 4, 2014
Start date January 2009
Est. completion date January 2012

Study information
Verified date April 2014
Source Association for Innovation and Biomedical Research on Light and Image
Contact n/a
Is FDA regulated No
Health authority Portugal: Health Ethic Committee
Study type Observational

Clinical Trial Summary

The purpose of this study is to validate and characterize phenotypes of diabetic retinopathy (DR) progression based on available clinical data (demographic, systemic and ophthalmic data).

Description:

This study aims to validate and characterize phenotypes of diabetic retinopathy (DR) progression using ophthalmic and systemic data from type-2 diabetic subjects followed at the AIBILI Clinical Trial Center in the last 10 years.

Macular Edema (ME) development during the study period, mainly Clinically Significant ME (CSME) needing treatment, will be the primary indicator for DR progression. CSME will be considered as the primary end-point and will be used to identify phenotypes (and risk markers) of DR progression.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date January 2012
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of DR.

- Females or Males;

- Age over 18 years;

- Signed Informed Consent;

- Previous follow-up with regular systemic and ophthalmic assessments.

Exclusion Criteria:

- Cataract or other eye disease that may interfere with fundus examinations;

- Vitreous syneresis or posterior vitreous detachment;

- Dilatation of the pupil < 5 mm.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Portugal AIBILI - Clinical Trial Center Coimbra

Sponsors (1)
Lead Sponsor Collaborator
Association for Innovation and Biomedical Research on Light and Image

Country where clinical trial is conducted

Portugal, 

References & Publications (1)

Cunha-Vaz J. Characterization and relevance of different diabetic retinopathy phenotypes. Dev Ophthalmol. 2007;39:13-30. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary CSME 1 year Yes
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