Phenotyping Diabetic Retinopathy

Association for Innovation and Biomedical Research on Light and Image

Status: Completed

Conditions: Diabetic Retinopathy

Study type: Observational

Funder types: Other

Identifiers

NCT00840541

CNTM018A

Details and patient eligibility

About

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).

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

80 participants in 1 patient group

DR

Description:

Type-2 diabetic subjects diagnosed with diabetic retinopathy (DR).