A Pilot Study to Assess the Safety of Proton Therapy for Subfoveal Neovascularization Associated With Age-Related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Visual acuity per comprehensive eye exam
研究概览
简要总结
This is a pilot study to determine if proton radiation therapy can provide effective and safe treatment for subfoveal neovascularization membrane (SNVM). The study will include adult patients over the age of 50 with macular degeneration, who have subfoveal neovascularization membrane (SNVM) and have had prior treatment with Avastin or Lucentis. Additional purposes of this study are to see if the growth of neovascular membranes can be stopped and overall vision improved with the use of protons and assess the side effects associated with this treatment.
详细描述
As part of this study, participants will have had a standard of care comprehensive eye exam by an Ophthalmologist to include visual acuity, fundus photography, fluorescein angiography and optical coherence tomography prior to treatment.
Participants will receive radiation using protons for 2 consecutive days. Each treatment will take 30 minutes. They will receive a total dose of 24 cobalt gray equivalent (CGE) in 2 treatments. A total of 10 participants will be enrolled on this study.
A comprehensive eye exam by an Ophthalmologist will be performed 30 days after radiation treatment with protons. Additionally, a physical examination per a Radiation Oncologist including a toxicity evaluation and comprehensive eye exam by an Ophthalmologist will be performed every 3 months for 1 year following radiation treatment.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with subfoveal neovascular membranes identified on fluorescein angiography.
- •Visual acuity (best corrected vision) 20/200 or worse in affected eye.
- •Patient must be 50 years of age or older at time of consent.
- •Patients must have had prior treatment for macular degeneration with Avastin (bevacizumab) or Lucentis (ranibizumab).
- •Women must be post menopausal or have had a hysterectomy.
排除标准
- •History of diabetes.
研究组 & 干预措施
Proton radiation
Proton radiation given to a total dose of 24 cobalt gray equivalent (CGE) in 2 treatments
干预措施: Proton radiation (Radiation)
结局指标
主要结局
Visual acuity per comprehensive eye exam
时间窗: 1 year after completion of radiation treatment
Number of participants with cessation of growth of neovascular membranes.
时间窗: 1 year after completion of radiation treatment
Frequency of intravitreal injections following radiation treatment
时间窗: 1 year after completion of radiation treatment
Number of participants with acute and late morbidity of the eye as a measure of safety
时间窗: 1 year after completion of radiation treatment
次要结局
未报告次要终点