Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00473330
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 RISE
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:
RISE
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 NCT00473382 Protocol ID FVF4168g
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
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