NCT04857177

A Study To Evaluate CKD-701 and Lucentis® in Patients With Neovascular(Wet) Age Related Macular Degeneration

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, Phase III Clinical Trial To Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of CKD-701 and Lucentis® in Patients With Neovascular(Wet) Age Related Macular Degeneration

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 312 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, active-controlled, parallel group, Phase III Clinical Trial To Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of CKD-701 and Lucentis® in Patients with Neovascular(wet) Age related Macular Degeneration

Detailed description

Subjects will be randomised in a 1:1 ratio to receive either CKD-701 or Lucentis®. Investigational Products (IP) (CKD-701 or Lucentis®) will be administered once a month during the loading phase(the first three months), and for the next nine months(PRN phase), administion will be determined based on the PRN administration criteria.

Conditions

• Neovascular(Wet) Age Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	CKD-701	CKD-701 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every one month during the loading phase, and intervals of one month based on criteria during the PRN phase.
DRUG	Lucentis®	Lucentis® (ranibizumab) 0.5mg via intravitreal injection every one month during the loading phase, and intervals of one month based on criteria during the PRN phase.

Timeline

• Start date: 2018-10-19
• Primary completion: 2021-03-17
• Completion: 2021-03-17
• First posted: 2021-04-23
• Last updated: 2021-04-23

Locations

1 site across 1 country: South Korea