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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)
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.
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.
Age
50 - 80 years
Sex
ALL
Healthy Volunteers
No
Peking Union Medical College Hospital
Beijing, China
Start Date
March 1, 2022
Primary Completion Date
December 20, 2023
Completion Date
September 23, 2024
Last Updated
February 5, 2026
443
ACTUAL participants
JL14002 monoclonal antibody(Fixed dosing regimen)
DRUG
Ranibizumab(Fixed dosing regimen)
DRUG
JL14002 monoclonal antibody(PRN)
DRUG
Ranibizumab(PRN)
DRUG
Lead Sponsor
Jecho Biopharmaceuticals Co., Ltd.
NCT06718816
NCT04932980
NCT05381948
Data Source & Attribution
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