NCT00954057已完成2 期
A Single-masked, Placebo Controlled, Multi-center Pilot Study to Determine the Safety and Efficacy of Orbital Injections of a Fixed Dose of LIPO-102 in Patients With Symptomatic Exophthalmos Associated With Thyroid-related Eye Disease
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
- 11
- 主要终点
- Safety: physical examinations, laboratory tests, VISA activity score, AE assessments
研究概览
简要总结
This is a pilot study to determine the safety and efficacy of orbital injections of LIPO-102.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Non pregnant female
- •Symptomatic exophthalmos
- •Inactive Thyroid Eye Disease
- •Signed informed consent
排除标准
- •Known hypersensitivity to study drugs
- •Treatment with an investigational agent within 30 days of first dose
- •History of Thyroid Eye Disease less than 6 months
- •Previous decompression surgery
研究组 & 干预措施
LIPO-102
Experimental
Intraorbital Injection
干预措施: LIPO-102 (Drug)
Placebo
Placebo Comparator
Intraorbital Injection
干预措施: Placebo (Drug)
结局指标
主要结局
Safety: physical examinations, laboratory tests, VISA activity score, AE assessments
时间窗: 8 weeks treatment and 1 week follow up
次要结局
- Efficacy: change in proptosis, VISA activity score, VAS for Eye Appearance Satisfaction(8 weeks treatment and 1 week follow up)
研究者
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