Ignite Creation Date:
2024-05-06 @ 12:02 AM
Last Modification Date:
2024-10-26 @ 10:43 AM
Study NCT ID:
NCT01472510
Status:
COMPLETED
Last Update Posted:
2014-03-14
First Post:
2011-11-03
Brief Title:
Ranibizumab in Residual Diabetic Macular Edema Following Previous Anti-VEGF Therapy
Sponsor:
Vitreo-Retinal Associates PC
Organization:
Vitreo-Retinal Associates PC
Study Overview
Official Title:
Ranibizumab in Residual Diabetic Macular Edema Following Previous Anti-VEGF Therapy
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 US Food and Drug Administration FDA for the treatment of wet age-related macular degeneration AMD and Retinal Vein Occlusion at the dose amount of 05 mg Ranibizumab has not been approved for use in subjects with DME
Ranibizumab has been approved by the US Food and Drug Administration FDA for the treatment of wet age-related macular degeneration AMD and Retinal Vein Occlusion at the dose amount of 05 mg Ranibizumab has not been approved for use in subjects with DME
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None