Viewing Study NCT04690556



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

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