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A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)

Age-Related Macular Degeneration Clinical Trial

Official title:
A Phase III Randomised, Double-masked, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity Between SB11 and Lucentis® in Subjects With Neovascular Age-related Macular Degeneration

Clinical Trial Summary

This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SB11 compared to Lucentis® in subjects with neovascular AMD.

Clinical Trial Description

Subjects will be randomised in a 1:1 ratio to receive either SB11 or Lucentis® (administered via intravitreal (ITV) 0.5 mg every 4 weeks). Investigational Products (IP) (SB11 or Lucentis®) will be administered up to Week 48, and the last assessment will be done at Week 52. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03150589
Study type Interventional
Source Samsung Bioepis Co., Ltd.
Contact
Status Completed
Phase Phase 3
Start date March 14, 2018
Completion date December 9, 2019
View Details
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