Ranibizumab in Residual Diabetic Macular Edema Following Previous Anti-VEGF Therapy
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Ranibizumab in Residual Diabetic Macular Edema Following Previous Anti-VEGF Therapy|
- Change in Visual Acuity Scores at Month 12 Compared to Baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Arm 1:The PRN Group
You will receive 6 monthly intravitreal injections of 0.5% Ranibizumab administered about every 28 days. It is possible you may receive additional injections into the study eye for the next six months if certain criteria is met.
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
Other Name: lucentis
Active Comparator: arm 2:The Monthly Group:
You will receive 12 monthly intravitreal injections of 0.5% Ranibizumab administered every 28 days.
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
Other Name: lucentis
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.
|United States, Massachusetts|
|Vitreo-Retinal Associates, PC|
|Worcester, Massachusetts, United States, 01605|
|Principal Investigator:||Frank J McCabe, M.D.||Vitreo-Retinal Associates, PC|
|Study Director:||Marie V Lampson||Vitreo-Retinal Associates, PC|