Influence of Oral Treatment with Citicoline for the Prevention of Radiation Optic Neuropathy in Patients Treated for Uveal Melanomas with Proton Beam Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 4
- 主要终点
- Occurrence and delay of occurrence of radiation optic neuropathy
研究概览
简要总结
Proton beam irradiation is the treatment of choice for uveal melanomas. It has favorable results in causing tumor regression while preserving the eye. Optic neuropathy has emerged consistently as an irreversible cause of visual loss in proton beam irradiated eyes. No neuroprotective strategies are available at present.
Citicoline is a choline agent precursor available as a dietary supplement. Citicoline conferred acute neuroprotection and enhanced neuroplasticity in experimental stroke models. In ophthalmology, citicoline has demonstrated a significant action in improving retinal and cortical responses in patients with optic nerve diseases (glaucoma, ischemic optic neuropathy). Citicoline also exhibits a very low toxicity profile in humans.
The purpose of the study is to demonstrate whether daily oral administration of citicoline in patients treated for uveal melanomas with proton beam therapy, prevents or delays the occurrence of radiation optic neuropathy. Changes in visual acuity, Pattern ERG and visual evoked potentials are measured. The tolerability/safety of the product is also evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •over 18 years old
- •uveal melanoma with posterior marge located at less than 3 mm of optic papilla
- •uveal melanoma treated with proton beam therapy with irradiation of optic head nerve
- •visual acuity before proton beam therapy over 30 letters (with ETDRS test)
排除标准
- •antecedent of acute glaucoma with angle enclosure
- •antecedent of chronical glaucoma with angle aperture
- •antecedent of optic neuropathy optique of congenital, ischemic, inflammatory or other origins
- •antecedent of neovascular glaucoma
结局指标
主要结局
Occurrence and delay of occurrence of radiation optic neuropathy
时间窗: Every 6 months
Occurrence and delay of occurrence of radiation optic neuropathy in patients treated for uveal melanomas with proton beam therapy
次要结局
- Visual function assessment(Every 6 months)