A Study to Compare SB15 (Proposed Aflibercept Biosimilar) to Eylea in Subjects With Neovascular Age-related Macular Degeneration (AMD)

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.

Timeline

Start

2020-06-23

Primary completion

2021-04-15

Completion

2022-03-16

Publications

• Woo SJ, Bradvica M, Vajas A, Sagong M, Ernest J, Studnicka J, Veith M, Wylegala E, Patel S, Yun C, Orski M, Astakhov S, Toth-Molnar E, Csutak A, Enyedi L, Kim T, Oh I, Jang H, Sadda SR. Efficacy and Safety of the Aflibercept Biosimilar SB15 in Neovascular Age-Related Macular Degeneration: A Phase 3 Randomized Clinical Trial. JAMA Ophthalmol. 2023 Jul 1;141(7):668-676. doi: 10.1001/jamaophthalmol.2023.2260.

Drugs

Indications