A Long-Term Follow-Up Study of ADVM-022 in Diabetic Macular Edema- INFINITY Extension
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Incidence of ocular and non-ocular adverse events (AEs)
研究概览
简要总结
This is a prospective, observational study designed to evaluate the long-term safety and tolerability of ADVM-022 in participants with diabetic macular edema (DME). Participants who previously participated in the INFINITY parent study and received a single unilateral intravitreal dose of ADVM-022 are eligible for enrollment upon completion of the end of study visit in the parent study.
详细描述
This is a multi-center study to evaluate the long-term safety and tolerability of a single intravitreal (IVT) injection of ADVM-022 in a preceding "parent" study, ADVM-022-04 [INFINITY]. Participants will be followed for a total of 5 years post- ADVM-022 administration (inclusive of the parent study). There is no investigational treatment administered in this study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have participated in the ADVM-022-04 [INFINITY] (parent) study and received ADVM-022
- •Must provide signed informed consent
- •Must be willing and able to comply with all study procedures
排除标准
- 未提供
结局指标
主要结局
Incidence of ocular and non-ocular adverse events (AEs)
时间窗: 168 Weeks
Severity of ocular and non-ocular AEs
时间窗: 168 Weeks
次要结局
- Change from Baseline in BCVA over time(168 Weeks)
- Incidence of 2-step and 3-step improvement in DRSS score over time(168 Weeks)
- Incidence of 2-step and 3-step worsening in DRSS score over time(168 Weeks)
- Frequency of supplemental aflibercept (2mg IVT) injections over time(168 Weeks)
- Occurrence of vision-threatening complications over time(168 Weeks)
- Incidence of CST < 300 μm over time(168 Weeks)
- Incidence of clinically significant findings via physical examinations, ocular examinations, imaging, and laboratory evaluation(168 Weeks)
- Time to worsening of DME disease activity(168 Weeks)
- Change from Baseline in central subfield thickness (CST) and macular volume over time measured by SD-OCT(168 Weeks)