Blood-retinal Barrier Imaging and Neuropsychiatric Sequela in Type 2 Diabetes Mellitus

Soroka University Medical Center

Status: Unknown

Conditions: Diabetic Macular Edema; Non-Proliferative Diabetic Retinopathy; Type 2 Diabetes Mellitus

Study type: Observational

Funder types: Other

Identifiers

NCT01107132

SOR495710ctil

Details and patient eligibility

About

In Type 2 Diabetes mellitus patients we will:

1. quantify vasculopathy and blood-retinal barrier (BRB) leakage
2. measure blood-brain barrier (BBB) permeability and neuroanatomical changes
3. correlate BRB pathology with BBB breakdown, inflammatory markers and neuropsychiatric sequela

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

1. T2DM Patient suffering from Non-Proliferative Diabetic Retinopathy (NPDR), Proliferative Diabetic Retinopathy (PDR) and Diabetic Macular Edema (DME) who are in the clinical database of the ophthalmologic department , above 18 years old at the time of diagnosis and underwent FA examination in the past three years
2. Patients which their medical records are available via a computerized data base

Control group:

1. T2DM patients who are in the clinical database of the ophthalmologic department
2. Above 18 years old at the time of diagnosis
3. Underwent FA examination in the past three years and their examination was interpreted as "normal", i.e. without suspected diabetic retinopathy

Trial design

100 participants in 1 patient group

Diabetic Retinopathy

Description:

T2DM Patient suffering from Non-Proliferative Diabetic Retinopathy (NPDR), Proliferative Diabetic Retinopathy (PDR) and Diabetic Macular Edema (DME)