An Open-Label, Single-Arm Phase IIIb Study in Patients With Neovascular Age-Related Macular Degeneration or Macular Edema Secondary to Retinal Vein Occlusion to Evaluate the Usability of Lucentis® 0.5 mg Prefilled Syringe
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- Percentage of Successful Task Completions
研究概览
简要总结
This is a multicenter study designed to evaluate usability of ranibizumab PFS in patients with neovascular age related macular degeneration or macular edema secondary to retinal vein occlusion.
详细描述
The purpose of this study is to assess the ability of HCPs to follow the instructions for use (IFU) to prepare and administer a ranibizumab PFS ITV injection dose to patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Study eye deemed to be indicated for ranibizumab ITV therapy at the discretion of the retina specialist
排除标准
- •Concurrent Ocular Conditions
- •Patients legally blind in one or both eyes
- •History of or any current clinically relevant intraocular inflammation or ocular inflammatory reaction (any grading from trace and greater is excluded), including non-infectious uveitis or uveitis, or sterile inflammatory reaction after the past ITV injections with any agent
- •Active disorder of ocular adnexa and skin in the study eye, including ocular surface infections
- •History of or any current indication of excessive bleeding and recurrent hemorrhages, including any prior excessive intraocular (including subconjunctival) bleeding or hemorrhages after ITV injection or intraocular procedures
- •Uncontrolled intraocular pressure greater than (>) 25 millimeters of mercury (mmHg) in the study eye (uncontrolled means that it occurs even with intraocular pressure-lowering therapy)
- •Use of therapies that are known to be toxic to any ocular tissues within the 6 months prior to enrollment
- •Prior Ocular Therapies
- •Treatment with any ITV injection within the 27 days prior to Day 1
- •Any invasive intraocular surgery, prior long-acting therapeutic agent, or ocular drug release device implantation (approved or investigational) in the study eye at any time during the past 3 months
- •Receipt of any systemic (non-ocular) investigational drug within 3 months prior to Day 1
- •Current systemic coagulation or bleeding disorders and history of recurrent hemorrhages
- •Intolerance or known reaction to prior biological therapies
- •History of other diseases or physical or laboratory examination findings that per the retina specialist represent a contraindication to ranibizumab use in the patient or may represent an unwarranted patient risk.
- •Uncontrolled hypertension (systolic >160 mmHg and/or diastolic >100 mmHg while sitting)
- •Current systemic infectious disease or a therapy for active infectious disease
- •Pregnant or lactating
研究组 & 干预措施
Ranibizumab PFS
Healthcare professionals (HCPs) will administer ITV injections of ranibizumab 0.5 mg delivered via PFS to enrolled patients (1 injection to each patient) on Day 1.
干预措施: Ranibizumab (Drug)
结局指标
主要结局
Percentage of Successful Task Completions
时间窗: Day 1
Product use tasks included sequence of steps starting from opening the carton, removing contents from carton to disposing of used PFS and needle. Tasks were considered to be successfully completed if the correct results were achieved without a use error, even if the instructions for use (IFU) were not followed exactly (example: not removing the needle cap prior to adjusting a dose). Usage error was defined as user action or lack of user action while using the medical device that led to a different result than intended by the manufacturer or expected by the user. The ability of HCPs to follow the IFU to prepare and administer a ranibizumab PFS ITV injection dose to patients was evaluated by successful task completion.
Percentage of PFS Usage Errors on Safety Critical Tasks
时间窗: Day 1
Usage error was defined as user action or lack of user action while using the medical device that led to a different result than intended by the manufacturer or expected by the user. Safety critical tasks where those in which use error could have a reasonably foreseeable potential for clinical impact or harm.
Percentage of PFS Usage Errors on Essential Tasks
时间窗: Day 1
Usage error was defined as user action or lack of user action while using the medical device that led to a different result than intended by the manufacturer or expected by the user. Essential tasks were those that were required in order to complete the use process for effective use of the product.
次要结局
未报告次要终点