Phase I/II Prospective, Randomized, Double-blinded Study of Intravitreal Anti-VEGF Therapy Combined With Proton Beam Radiation Versus Sham Irradiation in Treating Exudative Age-related Macular Degeneration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Percent of Eyes With Severe Ocular Adverse
研究概览
简要总结
The purpose of this study is to test the hypothesis that proton beam irradiation combined with intravitreal anti-VEGF therapy is safe and potentially more effective than intravitreal anti-VEGF therapy alone in eyes with exudative age-related macular degeneration.
详细描述
Radiation combined with anti-VEGF therapy has been shown to be synergistic in treating cancer and result in sustained tumor regression. On-going clinical trials have shown potential synergism between intravitreal anti-VEGF therapy and epiretinal brachytherapy administered during vitrectomy surgery in treating eyes with exudative age-related macular degeneration (eAMD). In this study, we test the hypothesis that radiation to the macula administered noninvasively via proton beam is well-tolerated in eyes with eAMD when combined with intravitreal anti-VEGF therapy and that this combination therapy may act synergistically to result in sustained treatment effect in eyes with eAMD.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Subjects will be eligible if the following criteria are met:
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study
- •Age > 50 years
- •Patient related considerations
- •Able to maintain follow-up for at least 24 months.
- •Women must be postmenopausal without a period for at least one year.
- •Diagnosed with Age-related Macular Degeneration (ARMD) with active subfoveal choroidal neovascular membrane (CNVM), newly diagnosed or treated with first dose of anti-VEGF therapy within 6 weeks of enrollment
- •Visual acuity 20/40 to 20/400
- •Lesion size < 12 Disc Area
- •Submacular hemorrhage less than 75% of total lesion and not involving foveal center
- •Submacular fibrosis less than 25% of total lesion
- •Candidate for intravitreal anti-VEGF therapy
排除标准
- •Subjects who meet any of the following criteria will be excluded from this study:
- •Prior enrollment in the study
- •Pregnancy (positive pregnancy test) or lactation
- •Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- •Participation in another simultaneous medical investigation or trial
- •Previous treatment with Photodynamic Therapy (PDT) or thermal laser in study eye
- •Anti-VEGF therapy within 6 weeks
- •Intravitreal or subtenon's Kenalog within 6 months
- •Intraocular surgery within 3 months or expected in the next 6 months
- •Current or planned participation in other experimental treatments for wet AMD
- •Other concurrent retinopathy or optic neuropathy
- •Other causes of CNVM, i.e. myopic degeneration or ocular histoplasmosis (POHS)
- •Significant media opacity precluding adequate view of the fundus for exam, photography or OCT
- •History of radiation therapy to the head or study eye
- •Diabetes mellitus or hemoglobin A1c > 6
- •Head tremor or h/o claustrophobia precluding positioning for proton irradiation
- •Inability to maintain steady fixation with either eye
- •History of Malignancy treated within 5 years
- •Allergy to Fluorescein dye
研究组 & 干预措施
24GyE + anti-VEGF
干预措施: 24GyE proton and Anti-VEGF (Drug)
16GyE + anti-VEGF
干预措施: 16GyE and anti-VEGF (Drug)
Sham Irradiation + anti-VEGF
干预措施: Sham Irradiation and anti-VEGF (Drug)
结局指标
主要结局
Percent of Eyes With Severe Ocular Adverse
时间窗: Month 24
vision loss of 3 or more lines associated with radiation retinopathy or papillopathy
次要结局
- Number of Anti-VEGF Injections Administered(Month 24)