A Study in Patients With Diabetic Macular Edema or Neovascular Age-Related Macular Degeneration to Evaluate a High Dose Aflibercept (8 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
- 3
- 主要终点
- Number of 8 mg aflibercept injections successfully administered utilizing the PFS
研究概览
简要总结
Regeneron Pharmaceuticals developed a single-dose pre-filled syringe (PFS) to deliver 8 mg aflibercept. The PFS is a convenient device that contains the study medication that will be injected in your study eye. A PFS offers a sterile, single dose of study drug within the syringe; this eliminates the need for the retina specialist to prepare the injection syringe from a separate vial.
This Phase IIIb study is focused on patients with diabetic macular edema (DME) and neovascular (wet) age-related macular degeneration (nAMD).
The main aim of the study is to evaluate if the 8 mg aflibercept PFS allows for successful preparation and administration of 8 mg aflibercept by retina specialists. The study will also assess the safety of 8 mg aflibercept PFS use. Regeneron will use the information from the study to better understand if the PFS can be used safely and effectively by retina specialists to administer 8 mg aflibercept.
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
- •Patient must have diabetic macular edema (DME) or neovascular "wet" age-related macular degeneration (nAMD) in the study eye
- •Study eye considered by the retina specialist to be eligible for treatment with 8 mg aflibercept
排除标准
- •Any active intraocular inflammation or infection in either eye or history of intraocular inflammation or infection after past IVT injections with any agent in either eye
- •Treatment with any IVT injection in the study eye within the 25 days prior to day 1
- •Intraocular pressure (IOP) >25 mm Hg in the study eye at screening
- •Any intraocular surgery in the study eye at any time during the past 3 months
- •Any prior extended-release therapeutic agent, or ocular drug-release device implantation (approved or investigational, including steroids) in the study eye
- •NOTE: Other protocol Defined Inclusion/Exclusion Criteria Apply
研究组 & 干预措施
8 mg Dose
Only 1 eye will be selected as the study eye by the investigator. Patients will receive a single dose utilizing the PFS.
干预措施: aflibercept 8 mg PFS (Drug)
结局指标
主要结局
Number of 8 mg aflibercept injections successfully administered utilizing the 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 adverse events (AEs) in the study eye(Through Day 29)
- Incidence of ocular severe adverse events (SAEs) in the study eye(Through Day 29)