A Randomized, Prospective, Active Controlled, Study of the Epi-Rad90™ Ophthalmic System for the Treatment of Subfoveal Choroidal Neovascularization Associated With Wet Age-Related Macular Degeneration
试验速览
- 阶段
- 3 期
- 发起方
- NeoVista
- 入组人数
- 494
- 试验地点
- 32
- 主要终点
- Percentage of subjects losing fewer than 15 letters of best corrected visual acuity score at 12 months compared to baseline. Gain of 15 more letters of best correct visual acuity score compared to baseline
研究概览
简要总结
The objective of the CABERNET Trial is to evaluate the safety and efficacy of focal delivery of radiation for the treatment of subfoveal choroidal neovascularization (CNV) associated with wet age-related macular degeneration (AMD). The Epi-Rad90™ Ophthalmic System treats neovascularization of retinal tissue by means of a focal, directional delivery of radiation to the target tissues in the retina. Using standard vitreoretinal surgical techniques, the sealed radiation source is placed temporarily over the retinal lesion by means of a handheld medical device.
详细描述
Therapeutic advances in the arena of neovascular age-related macular degeneration (AMD) have provided multiple treatment options for the disease. Radiotherapy has been studied in multiple clinical trials in the past with many studies showing a therapeutic benefit. Treatment with radiotherapy and anti-VEGF compounds is a promising approach to treating AMD.
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
- 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
- •Subjects must have predominantly classic, minimally classic, or occult with no classic lesions, as determined by the Investigator, secondary to AMD, with a total lesion size (including blood, scarring, and neovascularization) of < 12 total disc areas (21.24 mm2), and a GLD ≤5.4 mm
- •Subjects must be age 50 or older
排除标准
- •Subjects with prior or concurrent subfoveal CNV therapy including thermal laser photocoagulation (with or without photographic evidence), photodynamic therapy, injections with Macugen®, intravitreal or subretinal steroids, transpupillary thermotherapy (TTT), and systemic anti-angiogenic or intravitreal anti-angiogenic agents in study eye. (Note: This includes subjects with no known history, but with photographic evidence of prior therapy)
- •Subjects who underwent previous radiation therapy to the eye, head or neck
- •Subjects that have been previously diagnosed or have retinal findings consistent with Type 1 or Type 2 Diabetes Mellitus
研究组 & 干预措施
A
Epi-Rad90™ Ophthalmic System procedure + Lucentis
干预措施: Epi-Rad90™ Ophthalmic System (Device)
B
Lucentis only
干预措施: ranibizumab (Drug)
结局指标
主要结局
Percentage of subjects losing fewer than 15 letters of best corrected visual acuity score at 12 months compared to baseline. Gain of 15 more letters of best correct visual acuity score compared to baseline
时间窗: 12 months
次要结局
- Change in total lesion size and CNV size by fluorescein angiography(12 months)
- Number of rescue injections of Lucentis.(12 months)
- Mean change in ETDRS visual acuity(12 months)
- Incidence and severity of adverse events and ocular adverse events. Incidence of cataract changes. Incidents of radiation induced toxicity.(3 years)
- No loss in ETDRS letters(12 months)