NCT00333476终止2 期
A Phase 2, Randomized, Open Label, Safety, and Pharmacodynamic Study of Squalamine Lactate for Injection for the Treatment of Minimally Classic or Active Occult Choroidal Neovascularization Associated With Age-Related Macular Degeneration
Genaera Corporation18 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2006年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 140
- 试验地点
- 18
- 主要终点
- To evaluate the safety profile of squalamine lactate at doses ranging from 40 mg to 160 mg of squalamine lactate
研究概览
简要总结
Age-Related Macular Degeneration (AMD) is a degenerative eye disease of the retina that causes a progressive loss of central vision. AMD is the leading cause of legal blindness among adults age 50 or older in the Western world. AMD presents in two different types - "dry" and the more severe "wet" form. Wet AMD is caused by the growth of abnormal blood vessels in the macula. Squalamine lactate is an investigational drug that may prevent the growth of these abnormal blood vessels. This study will test the safety and efficacy of Squalamine in the treatment of AMD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects ≥ 50 years of age.
- •minimally classic or active occult choroidal neovascularization associated with age-related macular degeneration in one or both eyes.
- •baseline best corrected visual acuity score between 35 to 65 letters according to the Early Treatment of Diabetic Retinopathy Study protocol.
- •central retinal thickness by optical coherence tomography of > 250 microns.
- •lesions > 9 disc areas.
- •> 25% fibrosis in the lesion.
排除标准
- •Previous history of triamcinolone, bevacizumab, ranibizumab, or pegaptanib sodium injection therapy in the study eye.
- •retinal or optic nerve disease.
- •uncontrolled diabetes.
- •ongoing malignancy.
结局指标
主要结局
To evaluate the safety profile of squalamine lactate at doses ranging from 40 mg to 160 mg of squalamine lactate
次要结局
- To evaluate short-term effects on best corrected visual acuity and changes in subretinal CNV as measured by fluorescein angiography
- To evaluate short-term effects on best corrected visual acuity and changes in subretinal CNV as measured by optical coherence tomography
研究者
研究点 (18)
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