Compassionate Use of Anecortave Acetate: Clinical Protocol for the Treatment of Corticosteroid-induced Intraocular Pressure (IOP) Increases After Corneal Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Intraocular Pressure Within Normal Limits (<24 mm Hg)
研究概览
简要总结
This study will investigate the use of anecortave acetate injection to reduce intraocular pressure (IOP) in corneal transplant recipients who are experiencing steroid-associated pressure control problems. Alternative methods of IOP control have been shown to entail serious risks. For example, reduction of topical steroids increases the risk of graft rejection, and use of glaucoma medications or glaucoma surgery increases the risk of graft failure. This study is designed to have sufficient power to detect whether a single injection can induce a clinically significant IOP reduction.
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, Outcomes Assessor)
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
- •at least 18 years of age
- •corneal transplant recipient with intraocular pressure (IOP) greater than 24 mmHg and with relative increase in IOP of at least 10 mmHg over the pre-graft baseline
排除标准
- •not pregnant or lactating
- •intraocular surgery in the study eye within 30 days before enrolling in the study
- •use of any investigational drug or treatment within 30 days before receipt of study medication
- •clinical evidence of scleral thinning
研究组 & 干预措施
30 mg anecortave acetate
干预措施: 30 mg anecortave acetate (Drug)
15 mg anecortave acetate
干预措施: anecortave acetate (Drug)
结局指标
主要结局
Intraocular Pressure Within Normal Limits (<24 mm Hg)
时间窗: 1 month
Intraocular pressure was measured by Goldmann applanation tonometry.
次要结局
未报告次要终点