Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04690556
Status:
COMPLETED
Last Update Posted:
2021-03-05
First Post:
2020-11-23
Brief Title:
Study to Compare Efficacy and Safety of LUBT010 and Lucentis in Patients With Neovascular AMD
Sponsor:
Lupin Ltd
Organization:
Lupin Ltd
Study Overview
Official Title:
A Global Phase III Double Blind Randomized Controlled Study to Compare the Efficacy Safety Immunogenicity of LUBT010 With Lucentis in Patients With Neovascular Age Related Macular Degeneration
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
RECRUITING
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 compare the efficacy safety and immunogenicity of LUBT010 with Lucentis given as once monthly intravitreal injection in patients with neovascular age-related macular degeneration AMD
Detailed Description:
This is a global phase III double blind randomized controlled study to compare the efficacy safety immunogenicity of LUBT010 with Lucentis in patients with neovascular age-related macular degeneration
Eligible patients will be randomly assigned in 11 ratio to receive once monthly intravitreal injection of LUBT010 or Lucentis for 12 months
Eligible patients will be randomly assigned in 11 ratio to receive once monthly intravitreal injection of LUBT010 or Lucentis for 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-004409-42 | EUDRACT_NUMBER | None | None |