Biomarkers of Diabetic Retinopathy Progression (C-Tracer)

Association for Innovation and Biomedical Research on Light and Image

Status: Completed

Conditions: Mild Nonproliferative Diabetic Retinopathy; Type 2 Diabetes Mellitus

Study type: Observational

Funder types: Other

Identifiers

NCT01607190

4C-2012-02

Details and patient eligibility

About

The purpose of this study is to validate a predictive model of diabetic retinopathy progression in patients with diabetes mellitus type 2 patients to clinically significant macular edema (CSME) needing treatment either photocoagulation or intravitreal injections (ITV) using non-invasive techniques.

Enrollment: 200 patients

Sex: All

Ages: 35 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus
• Age over 35 years-old
• Non-proliferative diabetic retinopathy (Levels 20 to 35, according the ETDRS criteria)
• Best Corrected Visual Acuity > 20/25 on the ETDRS chart
• Informed Consent

Exclusion criteria

• Previous laser therapy
• Other retinal vascular disease
• Glaucoma
• Recent intraocular surgery (in the last 6 months)
• Inadequate ocular media and/ or pupil dilatation that do not permit good quality fundus photography (e.g. cataract)
• HbA1C > 11 % at the Screening
• Subject that has a condition or that is in a situation which may put him/her at significant risk, may confound the study results or may interfere significantly with his/ her participation in the study.

Trial design

200 participants in 1 patient group

Patients with diabetic retinopathy.