NCT00986362已完成2 期
The MIC (Microplasmin In Children) Trial: A Randomized, Placebo-controlled, Double-masked, Clinical Trial of Intravitreal Microplasmin in Infants and Children Scheduled for Vitrectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Percentage of Eyes With Total Macular Posterior Vitreous Detachment (PVD).
研究概览
简要总结
To evaluate the safety and preliminary efficacy of intravitreal microplasmin as an adjunct to conventional vitrectomy for the treatment of pediatric patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female infants or children 16 years of age or younger
- •Patient must be a suitable candidate for conventional 2-port or 3-port pars plana vitrectomy
- •Patient with attached vitreous somewhere in posterior pole
- •Patient's parent or guardian must be willing and able to comply with follow-up requirements
- •Patient's parent(s) must sign informed parental permission form and in the case of school-age children the patient must sign assent form
排除标准
- •Patient diagnosed with Stage 1, 2, 3 or 5 retinopathy of prematurity (ROP) at the time of surgery
- •Unclear media, which precludes assessment of the posterior pole such as a cataract or vitreal opacity
- •Active parental/guardian drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with parent's or guardian's adherence to study requirements
- •Medical problems that make consistent follow-up over the treatment period uncertain.
- •Patient must not have participated in an investigational drug or device study in the prior 30 days
- •Female Patients of childbearing potential must not be pregnant or lactating.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Ocriplasmin
Experimental
干预措施: Ocriplasmin (Drug)
结局指标
主要结局
Percentage of Eyes With Total Macular Posterior Vitreous Detachment (PVD).
时间窗: Beginning of vitrectomy or after application of suction
Percentage of eyes with total macular PVD (to the vascular ridge in eyes with ROP) at the beginning of vitrectomy or after application of suction, as assessed by masked surgeon observation under the operating microscope.
次要结局
未报告次要终点
研究者
研究点 (1)
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