An Open-label, Single-arm, Single-dose Clinical Trial to Evaluate the Safety and Usability of SB15 Pre-filled Syringe (PFS) in Trial Participants With Neovascular Age-related Macular Degeneration (AMD), Macular Oedema Secondary to Retinal Vein Occlusion (RVO), or Diabetic Macular Oedema (DME)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 33
- 试验地点
- 3
- 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 an open label, multicenter, Phase II trial to evaluate the safety and usability of the pre-filled syringe (PFS) of SB15 (Aflibercept biosimilar). Healthcare Professionals (HCPs) followed the Instructions for Use (IFU) to prepare and administer SB15 PFS with intravitreal injection to trial participants with nAMD, Macular Oedema Secondary to RVO, or Diabetic Macular Oedema (DME).
详细描述
HCPs will prepare and administer intravitreal injections of SB15 2 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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neovascular AMD, macular oedema secondary to RVO (branch RVO or central RVO), or DME in the study eye
- •Best Corrected Visual Acuity (BCVA) of ≥20/400 (letter score of ≥19) in the study eye and ≥20/800 (letter score of ≥4) in the fellow eye using original series Early Treatment Diabetic Retinopathy Study (ETDRS) charts or 2702 series Number charts at Screening and at Day 1
- •Study eye deemed to be indicated for continued aflibercept IVT therapy at the discretion of the retina specialist, and IP administration to be performed at the retina specialist's judgment
排除标准
- •History of and/or current intraocular inflammation (any grading from trace and greater is excluded), including non-infectious uveitis, infectious uveitis, or scleritis, or history of sterile inflammatory reaction after the past IVT injections with any agent in either eye
- •Active or suspected infectious disease (ocular or periocular) in either eye at Screening or at Day 1
- •History of excessive bleeding and recurrent haemorrhages, including any prior excessive intraocular bleeding or haemorrhages after IVT injection or intraocular procedures in either eye
- •History of massive subconjunctival haemorrhages of concern reported by the trial participant after an IVT injection in either eye
- •Current vitreous haemorrhage in the study eye
研究组 & 干预措施
SB15 PFS
Trial participants received a single dose of SB15 PFS containing 2 mg aflibercept in 0.05 mL solution.
干预措施: SB15 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.
Incidence of ocular adverse events (AEs)
时间窗: Day 1 to Day 7
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)