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Clinical Trial 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.


Clinical Trial Description

This is an open-label, single group, single dose study in subjects with nAMD or Macular Oedema Secondary to RVO. Screening and Day 1 can be performed on the same day. Subjects will receive ITV injection of SB11 PFS (0.5 mg ranibizumab in 0.05 mL) on Day 1, and follow up visit will be made on Day 1 (+2). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06176963
Study type Interventional
Source Samsung Bioepis Co., Ltd.
Contact
Status Completed
Phase Phase 2
Start date November 21, 2023
Completion date December 12, 2023

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