A Study to Evaluate the Usability of the SB11 PFS in Subjects With Wet AMD or Macular Oedema Secondary to RVO

Summary

This is a open label, multicenter, Phase II study to evaluate the usability of the pre-filled syringe (PFS) of SB11 (ranibizumab biosimilar). Healthcare Professionals (HCPs) followed the Instructions for Use (IFU) to prepare and administer SB11 PFS with intravitreal injection to subjects with nAMD or Macular Oedema Secondary to RVO.

Timeline

Start

2023-11-21

Primary completion

2023-11-30

Completion

2023-12-12

Publications

• Lee Y, Zalewski D, Oleksy P, Wylegala E, Orski M, Lee J, Kim S. Usability of the SB11 Pre-filled Syringe (PFS) in Patients with Retinal Diseases. Adv Ther. 2024 Aug;41(8):3426-3436. doi: 10.1007/s12325-024-02937-3. Epub 2024 Jul 8.

Drugs

Indications