Phenotyping Diabetic Retinopathy

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00840541

Enrollment

Registered

2009-02-10

Start date

2009-01-31

Completion date

2012-01-31

Last updated

2014-04-07

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

Conditions

Diabetic Retinopathy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
CSME	1 year

Countries

Portugal

Outcome results