NCT05003245

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: 407 (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 IVT with ranibizumab in patients with active CNV secondary to AMD.

Detailed description

This is a Phase 3, multicenter, randomized double masked active controlled study to compare the efficacy and safety of HLX04-O administered by IVT with ranibizumab in patients with active CNV secondary to AMD. The study will be conducted in approximately 60 sites in China. Either HLX04-O (1.25 mg) IVT or ranibizumab (0.5 mg) IVT will be administered at a 4-week interval for 1 year (12 cycles).

Conditions

• Age Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	HLX04-O，recombinant anti-vascular endothelial growth factor (VEGF) humanized monoclonal antibody ophthalmic injection	0.05mL solution at a 4-week interval for intravitreal injection
DRUG	Lucentis	0.05mL solution at a 4-week interval for intravitreal injection

Timeline

• Start date: 2021-11-01
• Primary completion: 2024-05-07
• Completion: 2024-05-07
• First posted: 2021-08-12
• Last updated: 2025-03-24

Locations

41 sites across 1 country: China