NCT01521065Unknown2 期
A Multicenter, Open-label Study to Evaluate the Clinical and Economic Benefits of Low Voltage Stereotactic Radiotherapy in Subjects With Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Rate of anti-VEGF injections during the first 12 months
研究概览
简要总结
The purpose of this study is to confirm the clinical and economic benefits of IRay treatment with respect to the number of anti-VEGF injections and frequency of visits during the first year after treatment for patients with wet Age-related Macular Degeneration (AMD).
详细描述
The objective of this study is to confirm the clinical and economic benefits of low voltage external beam radiotherapy with the IRay with respect to number of anti-VEGF injections and frequency of ophthalmic assessments during the one year interval following treatment in subjects with neovascular AMD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Must have neovascular AMD and have received an anti-VEGF injections within 1 month prior to entering the study, and have the need for further treatment with anti-VEGF therapy.
- •Must have a total lesion size of <12 disc areas and a CNV lesion with the greatest linear dimension of <6 mm, but not greater than 3 mm from the center of the fovea to the furthest point on lesion perimeter.
- •Must have provided informed consent, documented it in writing, and have been given a copy of the signed informed consent form.
- •Must be willing and able to return for scheduled treatment and follow-up examinations for the 3-year duration of the study.
- •Must be at least 50 years of age.
- •Women must be post-menopausal ≥1 year or surgically sterilized.
- •Must have best corrected visual acuity of greater than or equal to 24 letters in the study eye and at least 20 letters in the fellow eye (if both eyes meet all the study criteria, then the eye with the worst vision should be selected as the study eye).
排除标准
- •Present with any implanted device, where the device labeling specifically contraindicates subjects undergoing x-rays.
- •An axial length of <20 mm (because of limitations of the IRay device) or >26 mm (to exclude subjects with pathologic myopia).
- •Evidence of diabetes or retinal findings consistent with diabetic retinopathy, or retinopathy for any cause.
- •Prior or concurrent therapies in the study eye for age related macular degeneration (other than intravitreal anti-VEGF), including submacular surgery, subfoveal thermal laser photocoagulation (with or without photographic evidence), transpupillary thermotherapy (TTT) and ocular photodynamic therapy.
研究组 & 干预措施
16 Gy IRay
Experimental
16 Gy IRay + PRN Lucentis®
干预措施: IRay (Device)
结局指标
主要结局
Rate of anti-VEGF injections during the first 12 months
时间窗: 12 Months
次要结局
- Time to first Anti-VEGF injection(Up to Month 12)
- Change in mean best-corrected visual acuity in the treated eye at month 12(Month 12)
- Visual Functioning Questionnaire - 25 (VFQ-25)(Baseline & Month 12)
研究者
研究点 (1)
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