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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 705
- 试验地点
- 74
- 主要终点
- Change From Baseline in Best Corrected Visual Acuity (BCVA)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
SB11 (Proposed ranibizumab biosimilar)
干预措施: SB11 (Proposed ranibizumab biosimilar) (Drug)
Lucentis (ranibizumab)
干预措施: Lucentis (ranibizumab) (Drug)
结局指标
主要结局
Change From Baseline in Best Corrected Visual Acuity (BCVA)
时间窗: 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)
时间窗: 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
次要结局
未报告次要终点