Long-Term Follow Up of VOY-101 for Advanced Non-Neovascular Age-Related Macular Degeneration Extension Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 88
- 试验地点
- 4
- 主要终点
- Frequency of ocular and systemic VOY-101 related AEs
研究概览
简要总结
Long-Term Follow Up Extension for participants previously enrolled in a VOY-101 study for Advanced Non-Neovascular Age-Related Macular Degeneration
详细描述
This is a long-term observational, non-interventional extension study to the Phase 1/2a studies that administered VOY-101 to subjects with advanced non-neovascular age-related macular degeneration (AMD).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Have received an injection of VOY-101 and exited either the PBI-AMD-001 or PBI-AMD-002 Phase 1/2a study of VOY-
- •Are willing and able to understand and provide informed consent.
排除标准
- •There are no exclusion criteria for this study
研究组 & 干预措施
Rollover from PBI-AMD-001 and PBI-AMD-002 studies for those participants who received VOY-101
Long-term safety extension from PBI-AMD-001 and PBI-AMD-002 studies for those participants who received VOY-101
干预措施: observational study (Other)
Rollover from PBI-AMD-001 and PBI-AMD-002 studies for those participants who received VOY-101
Long-term safety extension from PBI-AMD-001 and PBI-AMD-002 studies for those participants who received VOY-101
干预措施: VOY-101 (Biological)
结局指标
主要结局
Frequency of ocular and systemic VOY-101 related AEs
时间窗: 3 years
Frequency of ocular and systemic VOY-101 related AEs (serious \[SAEs\] and treatment-emergent non-serious adverse events \[TEAEs\]).
次要结局
未报告次要终点