NCT00426998已完成2 期
A 24 Month Randomized, Double-Masked, Single Center, Phase II Study Comparing Photodynamic Therapy With Verteporfin (Visudyne)Plus Two Different Timing Regimens of Intravitreal Bevacizumab (Avastin) Given 1 Week Prior to or 1 Week Following Photodynamic Therapy in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration.
Retinal Consultants Medical Group1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2006年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- percentage of patients losing 3 or more lines of visual acuity
研究概览
简要总结
The purpose of this research study is to compare different timing therapies of Verteporfin with Bevacizumab to treat choroidal neovascularization (CNV) due to age-related macular degeneration (AMD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are men or women of age 55 or older
- •Patients have subfoveal CNV due to AMD with lesion size less than or equal to 9 MPS DA
- •patients have not received previous treatment for subfoveal CNV due to AMD.
- •Patients have a visual acuity between 20/40 and 20/320-
排除标准
- •Subjects who have received previous treatment for subfoveal CNV, in their study eye including prior PDT, transpupillary thermotherapy (TTT), submacular surgery, drug therapies such as Macugen or other anti-angiogenic compounds, or other local treatment. Previous laser photocoagulation therapy is acceptable, provided it was not subfoveal.
- •Patients with a known hypersensitivity/allergy to verteporfin, porfimer sodium, or other porphyrins, porphyria or other porphyrin sensitivity, or hypersensitivity to sunlight or bright artificial light.
- •Patients who use medications that may induce photosensitivity.
- •Patients who have undergone YAG capsulotomy within the last month.
- •Subjects currently involved in any experimental procedure within the last 12 weeks.
- •Female patients who are pregnant, fecund or breast-feeding.
结局指标
主要结局
percentage of patients losing 3 or more lines of visual acuity
percentage of patients gaining 3 or more lines of visual acuity
mean change from baseline in visual acuity
OCT evidence of active CNV leakage
fluorescein angiographic evidence of active CNV leakage
number of retreatments
次要结局
未报告次要终点
研究者
研究点 (1)
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