Phase 1/2a Dose Escalation Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
试验速览
- 阶段
- 1 期
- 入组人数
- 45
- 试验地点
- 3
- 主要终点
- Safety Endpoints
研究概览
简要总结
This safety study comprises a dose escalation study of VOY-101, followed by a cohort of subjects randomized to the maximum tolerated dose arm, a lower dose arm, and control arm.
详细描述
This is a prospective, multi-center safety phase 1/2a study to evaluate the safety of a single, unilateral intravitreal (IVT) injection of three dose levels of VOY-101 therapy in subjects with late-stage non-neovascular age-related macular degeneration (AMD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The Phase 1 cohorts will be open-label, the Phase 2a cohort will be 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
- •Are ≥50 years of age at the time of consent.
- •Are willing and able to understand and provide written informed consent.
- •Are willing and able to return for scheduled treatment and follow-up examinations.
- •Are able to undergo ETDRS BCDVA testing and ophthalmic imaging.
- •Well-demarcated GA secondary to AMD in the absence of MNV and in the absence of history of MNV.
- •Absence of signs of non-exudative MNV.
- •Additional Ocular Inclusion Criteria
- •Meet certain genotype criteria for risk of AMD.
排除标准
- •Are women of childbearing potential (WOCBP) and are pregnant or unwilling to use and document use of effective contraception for the duration of the study.
- •Additional Systemic, Ocular, and Genetic Exclusion Criteria.
研究组 & 干预措施
High Dose
VOY-101 High Dose (single dose, IVT)
干预措施: VOY-101 (Biological)
Mid Dose
VOY-101 Mid Dose (single dose, IVT)
干预措施: VOY-101 (Biological)
Low Dose
VOY-101 Low Dose (single dose, IVT)
干预措施: VOY-101 (Biological)
结局指标
主要结局
Safety Endpoints
时间窗: Through 24 months
1\. Frequency of ocular and systemic adverse events (AEs) (serious \[SAEs\] and treatment-emergent non-serious adverse events \[TEAEs\])
次要结局
未报告次要终点