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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Percentage of Successful Task Completions on All of the 12 tasks
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only one eye will be selected as the study eye.
- •Key Inclusion Criteria:
- •Neovascular AMD, macular oedema secondary to RVO, or mCNV in the study eye
- •Study eye deemed to be indicated for ranibizumab IVT therapy at the discretion of the ophthalmologist (e.g., retina specialist)
排除标准
- •BCVA of the level of Finger Count or worse [e.g., 0 letter reading using Early Treatment Diabetic Retinopathy Study (ETDRS) chart] in one or both eyes at Screening or at Day 1
- •Treatment with any IVT injection within the 30 days prior to Day 1 in the study eye
- •Uncontrolled intraocular pressure (IOP) greater than (≥) 25 mmHg in the study eye at Screening or at Day 1
- •Treatment with systemic (non-ocular) anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days prior to Day 1
- •Ocular laser surgery in study eye at any time within the past 30 days prior to Day 1
研究组 & 干预措施
SB11 PFS
Trial participants received a single dose of SB11 PFS containing 0.5 mg ranibizumab in 0.05 mL solution.
干预措施: SB11 PFS (Combination Product)
结局指标
主要结局
Percentage of Successful Task Completions on All of the 12 tasks
时间窗: Day 1
A total of 12 tasks were evaluated, and the percentage of HCPs' successful completions on all of the 12 tasks was measured.
次要结局
- Percentage of Successful Completion on Each of 12 tasks(Day 1)
- Incidence of AEs and serious adverse events (SAEs)(From Day 1 to Day 7)
- Change from baseline in Best Corrected Visual Acuity (BCVA)(From Day 1 to Day 7)