NCT00135837已完成4 期
An Open-Label, Multicenter, Phase 4 Study of the Effect of Verteporfin for Injection Therapy in Subjects With Occult With No Classic Choroidal NeoVascularization Secondary to Age-Related Macular Degeneration
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- visual acuity measurements, baseline, 12 months
研究概览
简要总结
Age related macular degeneration is the leading cause of blindness for people over 50 in the western world. Blood vessels which start to grow form a lesion in the back of the eye. Verteporfin may stabilize the disease, by closing the blood vessels. This study will assess the efficacy and safety of verteporfin in patients with occult only lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •50 years or older
- •Must see better or equal to 34 letters (visual acuity)
- •Choroidal neovascularization (CNV) lesion must be occult only
排除标准
- •Evidence of classic CNV in the lesion
- •Prior treatment of disease in study eye
- •Have a history of moderate to severe hepatic impairment
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
visual acuity measurements, baseline, 12 months
次要结局
- visual acuity measurements, fundus photographs and fluorescein angiography at baseline, 12 months; ophthalmic examinations, adverse events, vital signs, concomitant medications, 12 months
研究者
研究点 (1)
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