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Clinical Trial Summary

This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy, safety, Pharmacokinetics (PK), and immunogenicity of SB15 compared to Eylea® in subjects with neovascular AMD.


Clinical Trial Description

Subjects will be randomised in a 1:1 ratio to receive either SB15 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). At Week 32, subjects in Eylea® treatment group will be randomised again in a 1:1 ratio to either continue on Eylea® treatment or be transitioned to SB15 treatment. In the 8-week treatment cycle, IPs (SB15 or Eylea®) will be administered up to Week 48, and the last assessment will be done at Week 56, corresponding to the end of follow-up for all subjects. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04450329
Study type Interventional
Source Samsung Bioepis Co., Ltd.
Contact
Status Completed
Phase Phase 3
Start date June 23, 2020
Completion date March 16, 2022

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