NCT04690556

Study to Compare Efficacy, Safety, and Immunogenicity of LUBT010 (Proposed Ranibizumab Biosimilar) and Lucentis® in Patients With Neovascular AMD

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Lupin Ltd. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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 1:1 ratio to receive once monthly intravitreal injection of LUBT010 or Lucentis® for 12 months.

Conditions

• Neovascular Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	LUBT010 (proposed ranibizumab biosimilar)	LUBT010 (proposed ranibizumab biosimilar) 0.5 mg via intravitreal injection once monthly
DRUG	Lucentis (ranibizumab)	Lucentis® 0.5 mg via intravitreal injection once monthly

Timeline

• Start date: 2020-09-14
• Primary completion: 2024-05-31
• Completion: 2024-05-31
• First posted: 2020-12-30
• Last updated: 2026-01-29
• Results posted: 2026-01-06

Locations

78 sites across 7 countries: United States, Bulgaria, Hungary, India, Poland, Russia, Slovakia

Regulatory

• FDA-regulated drug study