A Pilot Study to Evaluate the Safety and Tolerability of the IRay Stereotactic Radiosurgery System in Subjects With Exudative Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
试验速览
- 阶段
- 1 期
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Incidence of ocular radiation-related adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and clinical feasibility of the IRay System for the treatment of wet age-related macular degeneration (AMD).
详细描述
The primary objective is to evaluate the safety and clinical feasibility of stereotactic radiotherapy with the Oraya IRay system for the treatment of choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD), as measured by incidence and severity of ocular radiation related serious adverse events (SAE) and adverse events (AE) in subjects treated with an 11, 16 or 24 Gray (Gy) macular dose through the 60-month follow-up visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 be age 50 or older
- •Women must be post-menopausal ≥1 year or surgically sterilized
- •Subjects must have choroidal neovascularization lesion size of ≤11 total disc areas (28.26mm), and a greatest linear dimension of ≤6 mm
- •Subjects must have Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity of 69 to 24 letters (20/40 to 20/320 Snellen Equivalent) in the study eye
- •Subretinal hemorrhage (if any) must not comprise more than 50% of total lesion size, and may not involve the subfoveal space
排除标准
- •Subjects with prior or concurrent therapies including submacular surgery, thermal laser photocoagulation (with or without photographic evidence), photodynamic therapy and transpupillary thermotherapy (TTT)
- •Subjects with concomitant disease in the study eye, including uveitis, diabetic retinopathy,presence of RPE tears or rips, acute ocular or periocular infection
- •Subjects with advanced glaucoma (>0.8 cup to disk ratio) or intraocular pressure ≥30 mmHg in the study eye
- •Previous glaucoma filtering surgery in the study eye
- •Refractive error in the study eye demonstrating more than -8 diopters of myopia (or globe axial length ≥26 mm). For subjects who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error cannot exceed -8 diopters of myopia
- •Subjects with any retinal vasculopathies, including diabetic retinopathy, retinal vein occlusions, etc. in the study eye
研究组 & 干预措施
11 Gy IRay
Day 0 Lucentis followed by 11 Gy IRay, Lucentis at Month 1 and Lucentis PRN (N = 2)
干预措施: IRay (Device)
16 Gy IRay
Day 0 Lucentis followed by 16 Gy IRay, Lucentis at Month 1 and Lucentis PRN (N = 27)
干预措施: IRay (Device)
16 Gy IRay - Radiation First
16 Gy IRay and Lucentis PRN (N = 13)
干预措施: IRay (Device)
24 Gy IRay
Day 0 Lucentis followed by 24 Gy IRay, Lucentis at Month 1 and Lucentis PRN (N = 19)
干预措施: IRay (Device)
结局指标
主要结局
Incidence of ocular radiation-related adverse events
时间窗: Month 12
次要结局
- Incidence of ocular adverse events(Through month 60)
- Percentage of subjects gaining ≥ 0 ETDRS letters(Month 12)
- Mean time to anti-VEGF retreatment following 2nd mandatory injection (excluding radiation-first subjects)(Month 12)
- Percentage of subjects who lose at least 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in best corrected visual acuity (BCVA)(Month 12)
- Mean change in ETDRS visual acuity(Month 12)
- Mean total number of ranibizumab injections(Through month 12 and 24)
- Change in choroidal neovascularization (CNV) size by fluorescein angiography (FA)(Month 12)
- Change in total lesion size by fluorescein angiography (FA)(Month 12)
- Change in central retinal lesion thickness by optical coherence tomography (OCT)(Month 12)
- Percentage of subjects gaining ≥ 15 ETDRS letters(Month 12)
- Change in central subfield thickness by optical coherence tomography (OCT)(Month 12)