Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-02-10 @ 2:19 PM
Study NCT ID:
NCT02698566
Status:
COMPLETED
Last Update Posted:
2017-09-21
First Post:
2016-02-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study in Patients With Neovascular Age Related Macular Degeneration or Macular Edema Secondary To Retinal Vein Occlusion to Evaluate Usability of the Ranibizumab (Lucentis®) Prefilled Syringe (PFS)
Sponsor:
Genentech, Inc.
Organization:
Study Overview
Official Title:
An Open-Label, Single-Arm Phase IIIb Study in Patients With Neovascular Age-Related Macular Degeneration or Macular Edema Secondary to Retinal Vein Occlusion to Evaluate the Usability of Lucentis® 0.5 mg Prefilled Syringe
Status:
COMPLETED
Status Verified Date:
2017-08
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 is a multicenter study designed to evaluate usability of ranibizumab PFS in patients with neovascular age related macular degeneration or macular edema secondary to retinal vein occlusion.
Detailed Description:
The purpose of this study is to assess the ability of HCPs to follow the instructions for use (IFU) to prepare and administer a ranibizumab PFS ITV injection dose to patients.
Study Oversight
Has Oversight DMC:
False
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?: