A Phase III Randomised, Double-masked, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity Between SB11 and Lucentis® in Subjects With Neovascular Age-related Macular Degeneration
Overview
- Phase
- Phase 3
- Intervention
- SB11 (Proposed ranibizumab biosimilar)
- Conditions
- Age-Related Macular Degeneration
- Sponsor
- Samsung Bioepis Co., Ltd.
- Enrollment
- 705
- Locations
- 74
- Primary Endpoint
- Change From Baseline in Best Corrected Visual Acuity (BCVA)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 50 years
- •Newly diagnosed, active subfoveal choroid neovascularisation (CNV) lesion secondary to AMD in the study eye
- •BCVA of 20/40 to 20/200 in the study eye
- •Written informed consent form
Exclusion Criteria
- •Any previous ITV anti-vascular endothelial growth factor (anti-VEGF) treatment to treat neovascular AMD in either eye
- •Presence of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture or pathologic myopia
- •Any concurrent macular abnormality other than AMD in the study eye
Arms & Interventions
SB11 (Proposed ranibizumab biosimilar)
Intervention: SB11 (Proposed ranibizumab biosimilar)
Lucentis (ranibizumab)
Intervention: Lucentis (ranibizumab)
Outcomes
Primary Outcomes
Change From Baseline in Best Corrected Visual Acuity (BCVA)
Time Frame: Baseline and Week 8
The VA was assessed using original series ETDRS charts or 2702 series number charts.
Change From Baseline in Central Subfield Thickness (CST)
Time Frame: Baseline and Week 4
The average retinal thickness in the central 1-mm area in the ETDRS grid (CST) was evaluated using (Optical Coherence Tomography) OCT