NCT01251978已完成2 期
Phase 2 Study to Evaluate the Efficacy of High Dose Ranibizumab as Adjuvant in the Treatment of Choroidal Melanoma
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
- 10
- 试验地点
- 1
- 主要终点
- To Evaluate the Safety/Efficacy of Intravitreal Injection of High Dose Ranibizumab Combined With TTT + ICG-based Photodynamic Therapy in the Treatment of Choroidal Melanoma by Reporting the Number of Participants With Complications.
研究概览
简要总结
Ranibizumab has proven to be of benefit to improve the perfusion in the retina of patients with Choroidal Melanoma. The investigators consider that higher doses of Ranibizumab can help reduce the number of laser treatments that might be needed to control the tumor.
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
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Primary pigmented or amelanotic choroidal melanoma measuring 16 mm or less in the largest basal diameter and 6 mm or less in the apical height.
- •Location of the tumor, posterior to the equator of the eye.
- •Documented growth of tumor by A-B scan.
- •Ability to provide written informed consent and comply with the study assessment for the full duration of the study.
排除标准
- •Pregnancy or lactation.
- •Premenopausal women not using adequate contraception.
- •Current infection or inflammation in either eye.
- •Extension of tumor into the orbit.
- •Regional 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
High dose Ranibizumab
Active Comparator
6 patients will receive 3 injections of Ranibizumab (2 mg) a month apart.
干预措施: Ranibizumab 2 mg (Drug)
Standard Dose Ranibizumab
Active Comparator
6 patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.
干预措施: 0.5 mg Ranibizumab (Drug)
结局指标
主要结局
To Evaluate the Safety/Efficacy of Intravitreal Injection of High Dose Ranibizumab Combined With TTT + ICG-based Photodynamic Therapy in the Treatment of Choroidal Melanoma by Reporting the Number of Participants With Complications.
时间窗: 1 year
次要结局
- Visual Acuity (LogMar)(12 months)
- Tumor Thickness(baseline and 1 year)
研究者
研究点 (1)
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