An Open-label, Single Group, Single-dose Clinical Study to Evaluate the Usability of the Pre-filled Syringe of SB11 in Subjects With Neovascular Age-Related Macular Degeneration or Macular Oedema Secondary to Retinal Vein Occlusion
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 3
- 主要终点
- Percentage of Successful Task Completions
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 subjects with nAMD or Macular Oedema Secondary to RVO.
详细描述
This is an open-label, single group, single dose study in subjects with nAMD or Macular Oedema Secondary to RVO.
Screening and Day 1 can be performed on the same day. Subjects will receive ITV injection of SB11 PFS (0.5 mg ranibizumab in 0.05 mL) on Day 1, and follow up visit will be made on Day 1 (+2).
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
- •Neovascular AMD or macular oedema secondary to RVO in the study eye
- •Study eye deemed to be indicated for ranibizumab ITV therapy at the discretion of the ophthalmologist (e.g., retina specialist)
- •Aged 18 years and older at the time of signing the informed consent form (ICF)
- •Written ICF must be obtained from the subject prior to any study-related procedure (if the subject cannot read ICF, an impartial witness will be present during the entire informed consent discussion)
- •Willingness and ability to undertake all scheduled visits and assessments
排除标准
- •Best Corrected Visual Acuity (BCVA) of the level of Finger Count or worse [i.e., 0 letter reading using Early Treatment Diabetic Retinopathy Study (ETDRS) chart] in one or both eyes at Screening or at Day 1
- •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 ITV injections with any agent in either eye
- •Active or suspected infectious disease, or active disorder that preclude safe use of IP at the discretion of the Investigator, in either eye or adnexa of either eye at Screening or at Day 1
- •History of excessive bleeding and recurrent haemorrhages, including any prior excessive intraocular bleeding or haemorrhages after ITV injection or intraocular procedures in either eye
- •History of massive subconjunctival haemorrhages of concern reported by the subject after an ITV injection in either eye
- •Uncontrolled intraocular pressure (IOP) greater than (≥) 25 mmHg in the study eye at Screening or at Day 1
- •Treatment with any ITV injection within the 30 days prior to Day 1 in the study eye
- •Any invasive ocular surgery including retinal detachment surgery, long-acting ocular therapeutic agent/implant including corticosteroid, or ocular drug release device implant (approved or investigational) in the study eye within 90 days prior to Day 1 or planned intraocular surgery within next 28 days after Day 1
- •Ocular laser surgery in study eye at any time within the past 30 days prior to Day 1
- •Treatment with any ocular IP in either eye within 90 days prior to Day 1
- •Treatment with systemic anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days prior to Day 1
- •Receipt of any systemic (non-ocular) IP within 180 days prior to Day 1
- •Use of therapies that are known to be toxic to ocular tissue within the 180 days prior to Day 1, including, but not limited to, deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines, vigabatrin, or ethambutol
- •Known ocular or non-ocular conditions that per the ophthalmologist (e.g., retina specialist) represent a contraindication to ranibizumab use in the patient or may represent an unwarranted patient risk
- •Uncontrolled hypertension (defined as systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg while sitting confirmed after repeated measurement) at Screening or Day 1
- •Current systemic infectious disease or therapy for active infectious disease
- •Pregnant or lactating women at Screening or at Day 1
- •Note: Other Protocol Defined Inclusion/Exclusion Criteria Apply
结局指标
主要结局
Percentage of Successful Task Completions
时间窗: Day 1
Total of 12 tasks were evaluated, and the percentage of HCP's successful task completions were measured. Participating HCPs were allotted sufficient time to review the instructions for use (IFU) before preparing and administering the ITV injection on Day 1. HCP participants did not receive any additional training for the SB11 PFS prior to or during the study. "Percentage of successful task completions" was used as the unit of measure, as one SB11 PFS administration procedure is consisted of 12 tasks and the primary endpoint was the percentage of successful tasks completion among total attempts in this study.
次要结局
- Percentage of Successful Completion on Critical Tasks(Day 1)
- Percentage of Successful Completion on Essential Tasks(Day 1)