Status:
COMPLETED
Intravitreous Bevacizumab and Standard Metabolic Control for Diabetic Macular Edema - A Contrast Sensitivity Study
Lead Sponsor:
University of Sao Paulo
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
Prospective, randomized, masked and interventional study. Patients with diabetes mellitus (DM) 2, glycated hemoglobin (HbA1c) less than 11% and previously treated macular edema three months before wil...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT02308644
Start Date
February 1 2009
End Date
February 1 2013
Last Update
December 4 2014
Active Locations (1)
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1
University of Sao Paulo
São Paulo, São Paulo, Brazil, 05403-000