Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00473382
Status:
COMPLETED
Last Update Posted:
2017-04-17
First Post:
2007-05-13
Brief Title:
A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema ME With Center Involvement Secondary to Diabetes Mellitus RIDE
Sponsor:
Genentech Inc
Organization:
Genentech Inc
Study Overview
Official Title:
A Phase III Double-masked Multicenter Randomized Sham Injection-controlled Study of the Efficacy and Safety of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema With Center Involvement Secondary to Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2017-03
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:
RIDE
Brief Summary:
This study is a Phase III double-masked multicenter randomized sham injection-controlled study of the efficacy and safety of ranibizumab injection in patients with clinically significant macular edema with center involvement CSME-CI secondary to diabetes mellitus Type 1 or 2 This study is identical in design to study NCT00473330 Protocol ID FVF4170g
The open-label extension phase of the study was stopped after receiving FDA approval of the study drug ranibizumab for diabetic macular edema
The open-label extension phase of the study was stopped after receiving FDA approval of the study drug ranibizumab for diabetic macular edema
Detailed Description:
This study is composed of 3 phases 1 A 24-month controlled treatment period monthly treatment with ranibizumab 03 mg ranibizumab 05 mg or sham injection followed by 2 a 12-month treatment period in which patients randomized to the sham group who had not discontinued from treatment still masked could choose to receive monthly ranibizumab 05 mg while the 2 ranibizumab treatment groups continued on the same treatment they received in the first 2 years Patients who had not discontinued treatment by Month 36 were eligible to continue treatment with ranibizumab 05 mg as needed pro re nata PRN in 3 an extension phase of the study for up to 2 more years resulting in up to 5 years possible total treatment time for some patients
As per the protocol Genentech terminated the study approximately 30 days after approval of ranibizumab for diabetic macular edema in the United States
As per the protocol Genentech terminated the study approximately 30 days after approval of ranibizumab for diabetic macular edema in the United States
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