A Phase I Single Center Study of Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- incidence and severity of ocular adverse events and systemic adverse events
研究概览
简要总结
The purpose of the study is to investigate the safety and tolerability of the anti-VEGF (vascular endothelial cell growth factor) treatment, ranibizumab, in combination with proton beam irradiation for the treatment of choroidal melanoma by determining the incidence and severity of ocular adverse events. Systemic adverse events will also be evaluated. A secondary objective is to assess the efficacy of ranibizumab in reducing ocular complications that can occur after irradiation.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly diagnosed choroidal melanoma undergoing proton therapy
- •Tumors >15 mm in largest diameter and/or >5 mm in height
- •Tumors ≤ 15 mm in largest diameter and ≤ 5 mm in height located ≤ 3 mm from optic disc and/or macula, with best-corrected visual acuity 20/100 or better in study eye
排除标准
- •History of prior treatment for choroidal melanoma
- •Pregnancy or lactation
- •Presence of diabetic retinopathy
- •History of retinal vascular occlusion or other retinal vascular disease
- •Active ocular inflammation or history of uveitis in either eye
- •History of uncontrolled glaucoma (defined as intraocular pressure >30mmHg despite treatment with anti-glaucoma medication) or filtering surgery in the study eye
- •Previous intravitreal injections of Avastin® in the study eye or in the non-study eye within 30 days.
- •Concurrent use of systemic anti-VEGF therapy
研究组 & 干预措施
1.0 mg ranibizumab
1.0 mg intravitreal injection given bi-monthly for 22 months
干预措施: ranibizumab (Drug)
0.5 mg ranibizumab
0.5 mg intravitreal injection given bi-monthly for 22 months
干预措施: ranibizumab (Drug)
结局指标
主要结局
incidence and severity of ocular adverse events and systemic adverse events
时间窗: 12 months and 24 months after initial treatment
次要结局
- incidence of radiation-induced complications, vision loss and eye loss(12 months and 24 months after initial treatment)