NCT03150589

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 705 (actual)
• Sponsor: Samsung Bioepis Co., Ltd. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	SB11 (Proposed ranibizumab biosimilar)	SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks
DRUG	Lucentis (ranibizumab)	Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks

Timeline

• Start date: 2018-03-14
• Primary completion: 2019-05-24
• Completion: 2019-12-09
• First posted: 2017-05-12
• Last updated: 2021-05-21
• Results posted: 2021-05-21

Locations

75 sites across 9 countries: United States, Czechia, Germany, Hungary, India, Poland, Russia, South Korea, United Kingdom

Regulatory

• FDA-regulated drug study