NCT05345236

A Study to Compare QL1207 to Eylea® in Subjects With Wet Age-related Macular Degeneration (wAMD)

A Phase III Randomised, Double-masked, Parallel Group Study to Compare the Efficacy and Safety Between QL1207 (Proposed Aflibercept Biosimilar) and Eylea® in Subjects With Wet Age-related Macular Degeneration

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 366 (actual)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy and safety of QL1207 compared to Eylea® in subjects with wet AMD.

Detailed description

Subjects will be randomised in a 1:1 ratio to receive either QL1207 or Eylea® (administered via intravitreal \[IVT\] injection 2 mg \[0.05 mL\] every 4 weeks for the first 3 months (i.e., at Weeks 0, 4, and 8), followed by 2 mg \[0.05 mL\] once every 8 weeks ) . Subjects will be administered the study drug up to week 48, and the last assessment will be done at Week 52.

Conditions

• Wet Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Aflibercept	Intravitreal (IVT) injection

Timeline

• Start date: 2019-08-19
• Primary completion: 2022-01-25
• Completion: 2022-01-25
• First posted: 2022-04-25
• Last updated: 2022-04-25

Locations

1 site across 1 country: China