drugset / Trial / NCT04690556

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

NCT04690556

Phase 3 Completed 600 enrolled Lupin Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2020-09-14
Primary completion
2024-05-31
Completion
2024-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject LUBT010 Unknown 0.5 mg Intravitreal
Comparator Ranibizumab Monoclonal antibody 0.5 mg Intravitreal