NCT03102138进行中（未招募）不适用
Long Term, Open-Label, Safety Follow Up Study Following Transplantation of Pf-05206388 (Human Embryonic Stem Cell Derived Retinal Pigment Epithelium (RPE)) in Subjects with Acute Wet Age Related Macular Degeneration and Recent Rapid Vision Decline
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- incidence of serious adverse events and ocular adverse events
研究概览
简要总结
This is a safety follow-up study. Patients enrolled in B4711001 will be followed for a further 4 years with regular visits to assess safety.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- •Previous participation in Protocol B4711001 and received treatment with PF-
- •Subjects who are willing and able to comply with scheduled visits, and study procedures.
排除标准
- •there are no exclusion criteria
结局指标
主要结局
incidence of serious adverse events and ocular adverse events
时间窗: 4 years
incidence of serious adverse events and ocular adverse events will be monitored
次要结局
- Mean ETDRS BCVA and change from baseline (pre-implantation) at all timepoints.(4 years)
- Change from baseline (pre-implantation) in ETDRS (Early Treatment of Diabetic Retinopathy Study) best corrected visual acuity (BCVA)(4 years)
研究者
研究点 (1)
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