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).
HCPs will prepare and administer intravitreal injections of SB11 0.5 mg delivered via PFS to trial participants on Day 1 and safety follow-up will be assessed until Day 7.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
SB11 provided in a pre-filled syringe (PFS) containing 0.5 mg ranibizumab in 0.05 mL for intravitreal injection
Research site
Krakow, Poland
Research site
Olsztyn, Poland
Percentage of Successful Task Completions on All of the 12 tasks
A total of 12 tasks were evaluated, and the percentage of HCPs' successful completions on all of the 12 tasks was measured.
Time frame: Day 1
Percentage of Successful Completion on Each of 12 tasks
Time frame: Day 1
Incidence of AEs and serious adverse events (SAEs)
Time frame: From Day 1 to Day 7
Change from baseline in Best Corrected Visual Acuity (BCVA)
Time frame: From Day 1 to Day 7
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