NCT02988895进行中（未招募）不适用
A Prospective Study of Episcleral Brachytherapy for the Treatment of Neovascular Age-related Macular Degeneration
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Feasibility of the study intervention
研究概览
简要总结
This is a prospective, multi-site, safety and feasibility study of the SalutarisMD SMD-DA system for retrobulbar minimally invasive episcleral brachytherapy device in patients receiving and not responding to anti-VEGF therapy for nAMD. The trial will be open label and non-randomized. The study intervention is a one-time intervention and requires no alteration to the standard of care during the follow-up period.
详细描述
Subjects will receive a single brachytherapy treatment and 36 months of follow-up.
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
- •Diagnosis of active CNV or PCV due to nAMD
- •Poor or non-responsive to FDA approved intravitreal anti-VEGF therapy for nAMD
- •BCVA 20/63 or worse Snellen equivalent in the study eye
- •Ability to understand nature/purpose of trial and to provide informed consent
- •Ability to undergo diagnostic tests and surgical interventions
- •Ability to follow instructions and complete the trial including all scheduled visits and follow-up
排除标准
- •Neovascularization other than due to AMD
- •Sub-foveal lesion hemorrhage obscuring >50% of lesion
- •Targeted neovascular lesion with greatest linear dimension >3750 microns or <1000 microns as determined by angiography
- •Presence of subretinal fibrosis, including disciform scar, or retinal pigment epithelial (RPE) atrophy that is extensive or foveal threatening in the study eye
- •An existing retinal pigment epithelial (RPE) tear
- •Previous treatment (excluding vitamins) for nAMD in the study eye other than anti-VEGF therapy in the last 6 months
- •A change in anti-VEGF agent in the previous two administrations
- •Anticipate a change to the anti-VEGF agent during the conduct of the study
- •Other clinically significant ocular co-morbidity including, but not limited to, glaucoma, optic neuropathy of any cause, maculopathy / retinopathy of any cause other than nAMD, scleritis, enophthalmos, microphthalmia, or other co-morbidities that in the investigator's opinion could require medical or surgical intervention to prevent or treat visual loss or media opacity that might result from that condition (i.e. severe cataracts).
- •Previous intraocular surgery in study eye other than for uncomplicated phacoemulsification cataract extraction
- •High myopia indicated by a history of refractive error of - 6D or greater (spherical equivalent), demonstrated myopic degeneration, or axial length of >26.5mm.
- •Subjects with orbital structural abnormalities, such as small (axial length <21 mm), deep set globes or other globe dystopias that, in the investigator's clinical judgment, would require a change in the angle of insertion or increase the risk of structural damage from retrobulbar anesthesia, sub-Tenon's anesthesia, or retrobulbar device positioning.
- •Media opacity sufficient to preclude adequate fundoscopy, OCT, or angiography
- •Uncontrolled systemic diseases (e.g. controlled hypertension is acceptable)
- •Type I or type II diabetes mellitus
- •Any previous therapeutic radiation to the head or neck or other areas that may have resulted in a radiation dose to the retina.
- •On anticoagulation or dual anti-platelet therapy with abnormal coagulation panel results.
- •Patient unsuitable for IV or local anesthesia
- •Any contraindication to anti-VEGF, fluorescein, indocyanine green, topical and local anesthetics, topical antiseptics, or topical antibiotics to be used during the study
- •Active ocular or periocular infection or intraocular inflammation
- •Fellow eye with a BCVA of 20/63 Snellen Equivalent or worse, with advanced AMD (neovascular or non-exudative AMD with foveal geographic atrophy), or other vision threatening disease that is not eligible for vision restoring treatment (i.e. inoperable cataracts).
- •Fellow eye is receiving anti-VEGF therapy
- •Have received any investigational treatment for any indication in the previous 30 days
- •Any condition which, in the investigators' opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule or other study conduct
研究组 & 干预措施
episcleral brachytherapy
Experimental
single fraction of 24 Gy Strontium90 episcleral brachytherapy
干预措施: episcleral brachytherapy (Radiation)
结局指标
主要结局
Feasibility of the study intervention
时间窗: 1 day
Investigator ability to place the device and deliver a therapeutic dose
Tolerability of the study intervention
时间窗: During procedure
Subject pain score during procedure
Safety of the study intervention
时间窗: 26 weeks
Adverse event assessment
次要结局
未报告次要终点
研究者
研究点 (2)
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