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A Study to Evaluate the Usability of the SB11 PFS in Trial Participants With Wet AMD, Macular Oedema Secondary to RVO, or mCNV
Sponsor: Samsung Bioepis Co., Ltd.
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 trial participants with nAMD, Macular Oedema Secondary to RVO, or Myopic Choroidal Neovascularization (mCNV).
Official title: An Open-label, Single Group, Single-dose Clinical Study to Evaluate the Usability of the Pre-filled Syringe of SB11 in Trial Participants With Neovascular Age-Related Macular Degeneration, Macular Oedema Secondary to Retinal Vein Occlusion, or Myopic Choroidal Neovascularization
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-03-30
Completion Date
2026-04-09
Last Updated
2026-04-24
Healthy Volunteers
No
Conditions
Interventions
SB11 PFS
SB11 provided in a pre-filled syringe (PFS) containing 0.5 mg ranibizumab in 0.05 mL for intravitreal injection
Locations (2)
Research site
Krakow, Poland
Research site
Olsztyn, Poland