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
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
- 4
- 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
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 (4)
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