A Study to Compare SB15 (Proposed Aflibercept Biosimilar) to Eylea in Subjects With Neovascular Age-related Macular Degeneration (AMD)
brief 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.
detailed 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.
official title
A Phase III Randomised, Double-masked, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB15 (Proposed Aflibercept Biosimilar) and Eylea® in Subjects With Neovascular Age-related Macular Degeneration