A Phase 1 Dose-Escalation and Repeated-Dose Study of the Safety and Tolerability of Intravitreal Pozelimab in Participants With Geographic Atrophy
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 9
- 主要终点
- Occurrence of systemic TEAEs
研究概览
简要总结
This study is researching an experimental drug called pozelimab (called "study drug"). The study is focused on people with a condition where certain parts of the eye's retina stop working over time, which can make it harder to see. This is called geographic atrophy (GA).
The aim of the study is to see how safe and tolerable the study drug is when used as an injection in the eye.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is in the blood and the fluid in the eye at different times
- Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Part A will not be masked (Open label) and part B is masked
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study eye with diagnosis of GA of the macula secondary to AMD, as determined by the investigator
- •Study eye with total GA area measuring approximately one disc area or greater in size (2.5 mm^2 or larger) at screening, as determined by the Central Reading Center (CRC), as described in the protocol
- •Best-Corrected Visual Acuity (BCVA) of 60 letters or worse using the Early Treatment Diabetic Retinopathy Score (ETDRS) charts (Snellen equivalent of ~ ≤20/63) in the study eye at screening and baseline visit
排除标准
- •GA (macular atrophy) in either eye due to causes other than dry AMD
- •History or current evidence of macular neovascularization and/or retinal exudation in either eye
- •Concurrent eye disease (elevated Intraocular Pressure (IOP) >25mm Hg, diabetic retinopathy, ocular infections/inflammation)
- •Prior or current intravitreal (IVT) treatment of any kind for any indication in either the study or fellow eye, except complement inhibitor therapy for GA, as long as last dose was ≥3 months prior to screening
- •Any prior systemic treatment for dry AMD, except oral supplements or vitamins
- •History or current use of systemic complement inhibitor therapy
- •Note: Other protocol-defined Inclusion/ Exclusion criteria apply
研究组 & 干预措施
Part A
干预措施: Pozelimab (Drug)
Part B
干预措施: Pozelimab (Drug)
结局指标
主要结局
Occurrence of systemic TEAEs
时间窗: Through week 8
Part A
Occurrence of ocular Treatment-Emergent Adverse Event (TEAEs) in the study eye
时间窗: Through week 8
Part A
Occurrence of ocular TEAEs in the study eye
时间窗: Through week 16
Part B
Occurrence of systemic TEAEs
时间窗: Through week 16
Part B
次要结局
- Concentrations of pozelimab in serum(Through week 8)
- Magnitude of ADA to pozelimab(Through week 8)
- Concentrations of pozelimab in serum(Through week 16)
- Occurrence of Anti-Drug Antibody (ADA) to pozelimab(Through week 8)
- Magnitude of ADA to pozelimab(Through week 16)
- Occurrence of ADA to pozelimab(Through week 16)