This study is designed to confirm that the investigational drug Ranibizumab given by injection into the eye is safe and effective to use in people with diabetic macular edema (DME).
Ranibizumab works by blocking Vascular Endothelial Growth Factor (VEGF), a substance which is found in eyes with diabetic eye disease and which causes leakage from blood vessels. Several studies have suggested that eyes with DME may have very high levels of VEGF; therefore, Ranibizumab may be helpful in blocking VEGF and decreasing DME. Ranibizumab has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of wet age-related macular degeneration (AMD) and Retinal Vein Occlusion at the dose amount of 0.5 mg. Ranibizumab has not been approved for use in subjects with DME.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
A 0.5mg intravitreal injection of Ranibizumab will be administered to subjects. Subjects will receive 6 monthly consecutive ranibizumab injections. Study visits will be scheduled to occur every 28 days relative to the date of the first injection
A 0.5mg intravitreal injection of Ranibizumab will be administered to subjects. Subjects will receive 12 monthly consecutive ranibizumab injections. Study visits will be scheduled to occur every 28 days relative to the date of the first injection
Vitreo-Retinal Associates, PC
Worcester, Massachusetts, United States
Change in Visual Acuity Scores at Month 12 Compared to Baseline
Time frame: 12 months
Resolution of residual edema compared to baseline as determined by mean foveal thickness on Cirrus OCT 300 microns at Month 6 and Month 12.
Time frame: 12 months
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