NCT00198510已完成3 期
Phase III Safety and Efficacy Study of Vitrase (Ovine Hyaluronidase) for Ophthalmic Intravitreal Injection for Clearance of Severe Vitreous Hemorrhage
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 750
- 试验地点
- 73
- 主要终点
- Resolution of Vitreous Hemorrhage
研究概览
简要总结
The purpose of this study is to determine if intravitreal injection of Vitrase (ovine hyaluronidase) clears vitreous hemorrhage
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe vitreous hemorrhage that obscures visualization of the fundus on indirect ophthalmoscopy, that has been present >/= 1 month by history or exam
- •BCVA is worse than 20/200 at time of screening
排除标准
- •Corneal or lenticular abnormalities that preclude fundus observation
- •Ongoing ocular infection, inflammation or history of herpetic corneal lesion
- •Current or prior retinal detachment or retinal tears or breaks or intraocular tumor
- •More than 1 severe vitreous hemorrhage within 6 months
- •Previous vitrectomy for any reason
- •Hemorrhage is exclusively pre-retinal, or old & organized
- •Prior Vitrase for intravitreal injection in either eye
- •No light perception in either eye at any time
- •Known contraindications to study medication
- •Sickle cell disease
研究组 & 干预措施
Vitrase
Experimental
A single dose of 0.05 cc of Vitrase (hyaluronidase) for ophthalmic intravitreal injection is injected into the vitreous chamber.
干预措施: Vitrase (Drug)
结局指标
主要结局
Resolution of Vitreous Hemorrhage
时间窗: 3 months
Laser treatment of underlying cause of vitreous hemorrhage, or other surgical treatment, or documented evidence of macula \& at least 180 degrees of vitreous base, that vitreous hemorrhage cause is resolved
次要结局
- Incidence of complications & adverse events(12 months)
- Visual Acuity(3 months, 6 months, 12 months)
研究者
研究点 (73)
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