Follow-up Study to Assess Visual Function in Subset of Patients Who Have Previously Participated in the TG-MV-006 and TG-MV-007 Ocriplasmin Studies.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Evidence of clinically significant abnormality in visual function, including Best Corrected Visual Acuity (BCVA), Spectral Domain Optical Coherence Tomography (SD-OCT) abnormality, and/or Electroretinography (ERG) abnormality
研究概览
简要总结
The primary objective of this study is to assess visual function in up to 44 patients who have previously participated in either of the placebo controlled, ocriplasmin Phase III studies (TG-MV-006 or TG-MV-007).
详细描述
Non-interventional follow up study consisting of 1 patient visit to perform assessments to assess long term visual function
研究设计
- 研究类型
- Observational
- 时间视角
- Cross Sectional
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
- •Written informed consent obtained from the patient prior to inclusion in the follow-up study
- •Previous participation in either of the placebo controlled, ocriplasmin Phase III studies (TG-MV-006 or TG-MV-007)
排除标准
- 未提供
研究组 & 干预措施
Ocriplasmin
Subjects who were exposed to a single intravitreal injection of 125µg of ocriplasmin in a previous phase III study (TG-MV-006 or TG-MV-007)
干预措施: ocriplasmin (Drug)
Placebo
Subjects who were exposed to a single intravitreal injection of placebo in a previous phase III study (TG-MV-006 or TG-MV-007)
干预措施: placebo (Drug)
结局指标
主要结局
Evidence of clinically significant abnormality in visual function, including Best Corrected Visual Acuity (BCVA), Spectral Domain Optical Coherence Tomography (SD-OCT) abnormality, and/or Electroretinography (ERG) abnormality
时间窗: Visit 1
Consenting patients will attend one visit, at which an ocular history, visual acuity (ETDRS) and full ophthalmologic assessment, as well as SD-OCT, and ERG assessment will be obtained. All SD-OCTs and ERGs will be centrally read by a masked and independent central reader.
次要结局
未报告次要终点