Phase 1/2a Study of VOY-101 in Subjects With Advanced Non-Neovascular Age-Related Macular Degeneration (JOURNEY)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 27
- 主要终点
- Phase 1: To evaluate the safety and tolerability of a single intravitreal injection of escalating doses of VOY-101
研究概览
简要总结
The Phase 1 safety study of VOY-101 is comprised of escalating dose Cohorts, followed by a Phase 2 at the recommended phase 2 dose.
详细描述
The study has a prospective, open-label, multi-center, two-part design to evaluate a single, unilateral intravitreal (IVT) injection of VOY-101 in subjects with geographic atrophy (GA), the advanced form of non-neovascular age-related macular degeneration (AMD). Phase 1 followed a standard dose escalation model to establish safety and tolerability of VOY-101 and determine the recommended phase 2 dose. This dose is being used in the randomized Phase 2 part of the study to evaluate the safety and efficacy of VOY-101 in the study eye compared to untreated fellow eye.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Central Reading Center is masked.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are ≥60 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 for both eyes.
- •Absence of signs of non-exudative MNV.
- •Additional Ocular Inclusion Criteria for both eyes.
- •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
Medium
Single, unilateral, intravitreal injection of medium dose of VOY-101
干预措施: VOY-101 (Biological)
Intermediate
Single, unilateral, intravitreal injection of intermediate dose of VOY-101
干预措施: VOY-101 (Biological)
Low
Single, unilateral, intravitreal injection of low dose of VOY-101
干预措施: VOY-101 (Biological)
Higher
Single, unilateral, intravitreal injection of higher dose of VOY-101
干预措施: VOY-101 (Biological)
High
Single, unilateral, intravitreal injection of high dose of VOY-101
干预措施: VOY-101 (Biological)
结局指标
主要结局
Phase 1: To evaluate the safety and tolerability of a single intravitreal injection of escalating doses of VOY-101
时间窗: 24 Months
Frequency and type of ocular and systemic adverse events and non-serious treatment-emergent adverse events
Phase 1: Change from Baseline in markers of inflammation
时间窗: Baseline to Month 24
Change from Baseline in markers of inflammation including anterior chamber cells, vitreous cells, and retinal vasculitis and retinitis.
Phase 1: Establish the recommended Phase 2 dose in subjects with Geographic Atrophy.
时间窗: Month 12
Determine whether the maximum tolerated dose (MTD) has been reached (as determined by the occurrence of dose-limiting toxicities \[DLTs\]) and select the RP2D.
Phase 2: To evaluate the effect of VOY-101 in the study eye compared with untreated fellow eye on change in Geographic Atrophy lesion size.
时间窗: 15 Months
Change from Baseline in Geographic Atrophy lesion size
Overall effect of treatment on retinal structural health
时间窗: Week 48
GA growth rate and Change in Ellipsoid Zone Integrity
次要结局
- Phase 1: To evaluate the effect of VOY-101 on geographic atrophy lesion size and photoreceptors(Baseline through 24 Months)
- Phase 1/2: To establish the pharmacokinetic (PK) profile of VOY-101.(Baseline through 24 Months)
- Phase 1/2: To evaluate the effect of VOY-101 on best corrected distance visual acuity(24 Months)
- Phase 1/2: Development of macular neovascularization(Month 24)
- Phase 2: To further characterize the ocular and systemic safety and tolerability of VOY-101(24 Months)
- Phase 2: To evaluate the effect of VOY-101 in the study eye compared with untreated fellow eye on geographic atrophy lesion size and photoreceptors(Baseline through Month 24)
- Phase 2: To evaluate the effect of VOY-101 on low luminance visual acuity(Baseline through Month 24)
- Overall effect of treatment on retinal structural health(Weeks 36, 48, and 96)
- Effect of treatment on vision function(Change from baseline)
- Incidence of neovascular AMD(Baseline to Week 96)
- VOY-101 Safety(Baseline to Week 96)