This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SB11 compared to Lucentis® in subjects with neovascular AMD.
Subjects will be randomised in a 1:1 ratio to receive either SB11 or Lucentis® (administered via intravitreal (ITV) 0.5 mg every 4 weeks). Investigational Products (IP) (SB11 or Lucentis®) will be administered up to Week 48, and the last assessment will be done at Week 52.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
705
SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks
Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks
Change From Baseline in Best Corrected Visual Acuity (BCVA)
The VA was assessed using original series ETDRS charts or 2702 series number charts.
Time frame: Baseline and Week 8
Change From Baseline in Central Subfield Thickness (CST)
The average retinal thickness in the central 1-mm area in the ETDRS grid (CST) was evaluated using (Optical Coherence Tomography) OCT
Time frame: Baseline and Week 4
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