NCT04740671

A Phase 3 Study to Compare the Efficacy and Safety of HLX04-O with Ranibizumab in Subjects with WAMD

A Phase 3, Randomized, Double-masked, Active Controlled Study to Compare the Efficacy and Safety of HLX04-O Administered by Intravitreal Injection with Ranibizumab in Subjects with Wet Age-related Macular Degeneration (wAMD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 410 (actual)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study will compare the efficacy and safety of HLX04-O administered by intravitreal injection (IVT) with ranibizumab in patients with active wAMD.

Detailed description

This is a Phase 3, Randomized, Double-masked, Active Controlled Study to Compare the Efficacy and Safety of HLX04-O Administered by Intravitreal Injection with Ranibizumab in Subjects with wet Age-related Macular Degeneration (wAMD). This study will be conducted in approximately 90 sites in different countries or regions.

Conditions

• Age Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	HLX04-O	Biologic recombinant anti-VEGF humanized monoclonal antibody, developed by Shanghai Henlius Biotech, Inc.
DRUG	ranibizumab	Biologic anti-VEGF recombinant humanized monoclonal antibody fragment

Timeline

• Start date: 2021-07-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2021-02-05
• Last updated: 2025-01-03

Locations

126 sites across 15 countries: United States, Australia, Bulgaria, China, Czechia, France, Germany, Hungary, Italy, Latvia, Poland, Serbia, Singapore, Slovakia, Spain

Regulatory

• FDA-regulated drug study