Photodynamic Therapy With Visudyne for Human Retinoblastoma: A Preliminary Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- eye enucleation
研究概览
简要总结
To study the effectiveness and safety profiles of photodynamic therapy (PDT) for the treatment of human retinoblastoma.
详细描述
Retinoblastoma is the commonest primary intraocular malignancy in infancy and early childhood. Ophthalmologist are trying to seek other more safe and effective treatment modalities to well control the tumor and preserve the visual function. Photodynamic therapy (PDT) is a potentially therapeutic approach for retinoblastoma which has been underestimated. In this study, we are gonging to investigate the the effectiveness and safety profiles of photodynamic therapy (PDT) for the treatment of human retinoblastoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with intraocular retinoblastoma of Group A-D
排除标准
- •(1) patients with intraocular retinoblastoma of group E; (2) patients with extraocular spread; (3); media opacities such as corneal opacity, significant cataract, or vitreous hemorrhage obscuring fundus examination; (4) patients who were allergic to verteporfin or other benzoporphyrin derivatives.
研究组 & 干预措施
PDT treatment group
All the patients received once PDT with Visudyne® as the initial treatment. Rescue treatment with systemic chemotherapy would be given to patients if tumors were insensitive to PDT treatment, the tumors became larger, or disease relapse.
干预措施: photodynamic therapy (Drug)
结局指标
主要结局
eye enucleation
时间窗: 3 years
the rate of eye enucleation of patients with retinoblastoma in different groups
次要结局
未报告次要终点
研究者
Jin Chen-jin
Prof.
Sun Yat-sen University