NCT03767738已完成4 期
A Study in Patients With Chorioretinal Vascular Disease to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Number of Aflibercept Injections Successfully Administered Utilizing the Prefilled Syringe (PFS)
研究概览
简要总结
The primary objective of the study is to determine if the pre-filled syringe (PFS) supports successful preparation and accurate administration of an aflibercept injection.
The secondary objective of the study is to assess ocular safety in the study eye.
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
- •Participants who have neovascular age-related macular degeneration (AMD), diabetic macular edema (DME), retinal vein occlusion (RVO), or diabetic retinopathy (DR) with diabetic macular edema (DME) in the study eye
排除标准
- •Evidence of active infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye
- •Any active intraocular inflammation or infection in either eye or history of intraocular inflammation or infection after past intravitreal injection treatment (IVT) injections with any agent in either eye
- •History of or any current indication of excessive bleeding and recurrent hemorrhages, including any prior excessive intraocular (including subconjunctival) bleeding or hemorrhages after IVT injection or intraocular procedures in either eye
- •Any intraocular surgery in the study eye at any time during the past 3 months
- •Current systemic infectious disease or a therapy for active infectious disease
- •Pregnant or breastfeeding women
- •Note: Other inclusion/ exclusion apply
研究组 & 干预措施
Intravitreal Aflibercept Injection (IAI)
Experimental
Cohort 1 - Initial patients Cohort 2 - Additional patients
干预措施: Intravitreal Aflibercept Injection (IAI) (Drug)
结局指标
主要结局
Number of Aflibercept Injections Successfully Administered Utilizing the Prefilled Syringe (PFS)
时间窗: At Day 1
Participants received a single dose of study drug, administered in the selected study eye with the PFS by a retina specialist. Physician assessed successful aflibercept preparation and administration with the PFS.
次要结局
- Incidence of Ocular Serious TEAEs of Study Eye Through Day 29(Baseline through Day 29)
- Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29(Baseline through Day 29)
研究者
研究点 (1)
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