drugset
drugset / Trial / NCT03805100

Comparing the Efficacy and Safety of Biosimilar Candidate Xlucane Versus Lucentis® in Patients With nAMD

NCT03805100 ↗

Phase 3 Completed 582 enrolled Xbrane Biopharma AB Stada Arzneimittel AG · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

The objectives of the study are to demonstrate the equivalence of Xlucane to Lucentis® in treatment of subjects with wet (ie, neovascular) age-related macular degeneration (wAMD).

Timeline

Start
2019-04-19
Primary completion
2021-05-11
Completion
2021-11-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Ranibizumab Monoclonal antibody 0.05 ml Intravitreal
Subject Ranibizumab Monoclonal antibody 10 mg/ml Intravitreal

Indications

age-related macular degeneration