A Phase 2, Randomized, Open Label Study of AMDX-2011P as a Retinal Tracer in Participants With Primary Open Angle Glaucoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Amydis Inc.
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- AMDX-2011P Adverse Events Profile
研究概览
简要总结
The purpose of this research study is to assess the ability of AMDX- 2011P to identify amyloid deposits in the retina of participants with Primary Open Angle Glaucoma (POAG).
详细描述
This open-label, masked endpoint assessment study will evaluate safety, tolerability, plasma pharmacokinetics (PK) and biological activity of intravenous (IV) doses of AMDX-2011P in participants with POAG. Assessments of retinal images will be conducted by centrally masked assessors.
Participants will be admitted to the study site where eye examination and retinal imaging will be conducted before administration of the study drug. AMDX-2011P will be administered through a single IV bolus injection followed by safety assessments, retinal imaging, and blood collection and PK.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary open angle glaucoma in both eyes
- •Able to fixate
- •Glaucomatous optic nerve damage in both eyes, as determined by an investigator as part of an eye exam
排除标准
- •Participants unable to read or write
- •Ocular media is not sufficiently clear to obtain acceptable quality images
- •Participants with presence of any ocular pathology other than glaucoma in the study eye (cataracts are acceptable)
研究组 & 干预措施
AMDX-2011P 50 mg
AMDX2011P mg 50 (2ml) single bolus injection intravenous for diagnostic review
干预措施: AMDX-2011P (Drug)
AMDX-2011P 100 mg
AMDX2011P 100mg (4ml) single bolus injection intravenous for diagnostic review
干预措施: AMDX-2011P (Drug)
结局指标
主要结局
AMDX-2011P Adverse Events Profile
时间窗: 8 days
Incidence, nature and severity of AEs/SAEs
次要结局
- Concentration of AMDX-2011P(2 hours)
- Pharmacokinetic Analysis of AMDX-2011P(2 hours)
- Biological Activity(1 day)