NCT07389577

A Study to Compare JL14002 to Lucentis® in Subjects With Wet Age-related Macular Degeneration (wAMD)

A Randomized, Double-masked, Multicenter, Parallel Group, Phase 3 Clinical Trial to Compare the Efficacy and Safety of JL14002 Monoclonal Antibody Injection Versus Ranibizumab Injection in Patients With Neovascular (Wet) Age-Related Macular Degeneration (wAMD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 443 (actual)
• Sponsor: Jecho Biopharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy and safety of JL14002 compared to Lucentis® in subjects with wAMD.

Detailed description

Subjects will be randomised in a 2:1:1 ratio into the JL14002 Experimental Arm, Active Comparator Arm 1, and Active Comparator Arm 2. During the first 12 weeks, all subjects will receive fixed dosing at intervals of every 4 weeks (0.5 mg per dose), with a total of three consecutive doses. Subjects in the JL14002 experimental arm will receive JL14002 monoclonal antibody injection, while those in active comparator arm 1 and active comparator arm 2 will receive ranibizumab injection. Starting from week 12, all subjects will transition to a pro re nata (PRN) dosing regimen. Based on the PRN criteria assessed by the investigator, subjects in the JL14002 experimental arm and active comparator arm 1 will receive JL14002 monoclonal antibody injection as needed, while subjects in active comparator arm 2 will receive ranibizumab injection as needed. All subjects will be required to return to the study site every 4 weeks for safety and efficacy assessments.

Conditions

• Wet Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	JL14002 monoclonal antibody(Fixed dosing regimen)	For the first 12 weeks, a fixed dosing regimen will be administered, consisting of 0.5 mg JL14002 once every 4 weeks for a total of 3 consecutive doses.
DRUG	Ranibizumab(Fixed dosing regimen)	For the first 12 weeks, a fixed dosing regimen will be administered, consisting of 0.5 mg Ranibizumab once every 4 weeks for a total of 3 consecutive doses.
DRUG	JL14002 monoclonal antibody(PRN)	From Week 12 through Week 48, treatment will transition to a pro re nata (PRN) regimen. Patients will receive 0.5 mg of JL14002 monoclonal antibody injection as needed, based on pre-specified retreatment criteria.
DRUG	Ranibizumab(PRN)	From Week 12 through Week 48, treatment will transition to a pro re nata (PRN) regimen. Patients will receive 0.5 mg of Ranibizumab injection as needed, based on pre-specified retreatment criteria.

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-12-20
• Completion: 2024-09-23
• First posted: 2026-02-05
• Last updated: 2026-02-05

Locations

1 site across 1 country: China