Phenotyping Diabetic Retinopathy

Completed

• Conditions: Diabetic Retinopathy

• Registration Number: NCT00840541
• Lead Sponsor: Association for Innovation and Biomedical Research on Light and Image

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-02-09
• Study First Submitted QC: 2009-02-09
• Study First Posted: 2009-02-10
• Primary Completion: 2010-01
• Study Completion: 2012-01
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-04
• Last Update Posted: 2014-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CSME	1 year

Trial Locations

Locations (1)

AIBILI - Clinical Trial Center; 🇵🇹 Coimbra, Portugal