NCT00680225已完成3 期
Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Mean Tumor Thickness
研究概览
简要总结
To report preliminary results on safety and tolerability of intravitreal injection of Ranibizumab (Lucentis) combined with Transpupillary Thermotherapy (TTT)+ Indocyanine Green (ICG)-based photodynamic therapy (PDT) in the treatment of choroidal melanoma.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 yo.
- •Primary pigmented or amelanotic choroidal melanoma measurement of 16 mm or less in the largest vessel diameter and 6 mm or less in the apical height.
- •Location of the tumor posterior to the equator.
- •Documented growth by A/B scan.
- •Risk factor for metastasis (thickness greater than 2 mm, symptoms, tumor margin at the optic disc)
- •Ability to provide inform consent.
- •Comply with the study assessment for the cooperation of the study.
排除标准
- •Pregnancy or lactation.
- •Premenopausal women not using adequate contraception; surgical sterilization or use of oral contraception, barrier contraception with either a condom or diaphragm or in conjunction with spermicidal gel, an IUD or contraceptive hormon implant or patch.
- •Current infection or inflammation in either eye.
- •Extension of tumor into the orbit.
- •Retinal spread or metastatic disease.
- •Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
- •Any known allergy to any of the components to be used in the study.
- •Participation in another simultaneous medical investigation or trial.
研究组 & 干预措施
Lucentis Injection
Experimental
Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.
干预措施: Ranibizumab injection and TTT - ICG based (Drug)
结局指标
主要结局
Mean Tumor Thickness
时间窗: 12 mo
次要结局
- Visual Acuity Changes(12 mo)
研究者
研究点 (1)
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