NCT04572698

A Study to Compare LY09004 and Eylea in the Treatment of Wet Age-related Macular Degeneration（wAMD）

To Compare the Efficacy and Safety of Recombinant Human Vascular Endothelial Growth Factor Receptor Antibody Fusion Protein Eye Injection（LY09004） and Eylea in the Treatment of Wet Age-related Macular Degeneration（wAMD）: a Randomized, Double-blind, Parallel Controlled, Multicenter Clinical Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 416 (estimated)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

A randomized, double-blind, parallel controlled, multicenter clinical trial to compare the efficacy and safety of LY09004 and EYLEA in the Treatment of Wet Age-related Macular Degeneration（wAMD)

Detailed description

This is a randomized, double-blind, parallel controlled, multicenter clinical trial. The primary objective is to assess the efficacy similarity of LY09004 and EYLEA in the treatment of w-AMD. The secondary objective is to assess the safety similarity of LY09004 and EYLEA in the treatment of w-AMD.

Conditions

• Age Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	LY09004	LY09004 injection by intraocular injection on Day1, Day29, Day57,Day113, Day169, Day225, Day281 and Day337.
DRUG	Eylea	EYLEA injection by intraocular injection on Day1, Day29, Day57,Day113, Day169, Day225, Day281 and Day337.

Timeline

• Start date: 2020-11-01
• Primary completion: 2023-06-01
• Completion: 2023-12-01
• First posted: 2020-10-01
• Last updated: 2020-10-01