Intravitreous Bevacizumab and Standard Metabolic Control for Diabetic Macular Edema - A Contrast Sensitivity Study

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the effects on contrast sensitivity (CS) measurements of intravitreal bevacizumab injections associated with standard metabolic control in eyes with diabetic macular edema (DME) associated with standard metabolic control.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

• Age at least 18 years old, of both genders;

• Patients with diabetes mellitus type I or type II;

• Macular edema presence of clinically significant diabetic in their mixed or diffuse;

• Visual acuity worse than 20/40 corrected (< 68 letters ETDRS)

• Glycated hemoglobin ≤ 11%;

• Systolic and diastolic blood pressure < 170 and < 100 mmHg, respectively;

• Women not pregnant;

• Free and informed consent term signed the screening visit;

• Ability to adhere to the visits.

Exclusion Criteria:

• Failure to comply with any of the inclusion criteria;

• Treatment for DME within the prior 3 months;

• Vitreoretinal traction within 1 disc diameter (DD) of the fovea, clinically confirmed or with OCT;

• Atrophy or fibrosis surrounding the fovea;

• Any level of cataract;

• Vitreous hemorrhage or any opacity means;

• Eye disease related to diabetic retinopathy that can derail the central vision (eg Age Macula Degeneration, chorioretinitis scar, ...)

• Best-corrected visual acuity to 20/40 (> 68 letters ETDRS)

• Inability to understand the treatment and the term of consent;

• Debilitating systemic disorders that preclude the patient's admission to the study, according to the clinical judgment of the investigator;