NCT05461339

TAB014 Compared to Lucentis® in Patients with Neovascular Age-related Macular Degeneration

A Phase III, Randomized, Multicenter, Doubled-blind Clinical Trial Comparing the Efficacy and Safety of TAB014 and Lucentis in Neovascular Age-related Macular Degeneration (nAMD) Patients

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 488 (estimated)
• Sponsor: BioDlink Biopharm Co., Ltd. · Industry
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, multi-center, double blind, Lucentis controlled non-inferiority study in neovascular age-related macular degeneration patients. The objective of this study is to compare the efficacy and safety of TAB014 and ranibizumab (Lucentis).

Detailed description

Primary Objectives: To evaluate the efficacy of TAB014 compared to Lucentis in neovascular age-related macular degeneration patients Secondary Objectives: 1. To evaluate the safety of TAB014 compared to Lucentis in neovascular age-related macular degeneration patients. 2. To evaluate the immunogenicity of TAB014 in neovascular age-related macular degeneration patients.

Conditions

• Neovascular Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	TAB014 Monoclonal Antibody Injection	intravitreal injection at 1.25mg once every 4 weeks
DRUG	Ranibizumab Injection [Lucentis]	intravitreal injection at 0.5mg once every 4 weeks

Timeline

• Start date: 2022-06-28
• Primary completion: 2024-09-20
• Completion: 2025-02-01
• First posted: 2022-07-18
• Last updated: 2025-01-07

Locations

56 sites across 1 country: China

Regulatory

• FDA-regulated drug study