NCT01339949撤回不适用
A Double-masked, Sham Controlled, Study to Evaluate the Safety and Effectiveness of Low Voltage Stereotactic Radiosurgery in Wet AMD Patients With Recurrent Leakage Secondary to CNV
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- Number of Lucentis injections during first 52 weeks
研究概览
简要总结
The objective of this study is to confirm the safety and to establish the effectiveness of low voltage external beam radiosurgery using the IRay System for the treatment of subjects with recurrent leakage secondary to neovascular Age-related Macular Degeneration (AMD) as determined by decreasing the number of Lucentis injections required during the first 12 months of the study.
详细描述
The objective of this study is to confirm the safety and to establish the effectiveness of low voltage external beam radiosurgery using the IRay System for the treatment of subjects with recurrent leakage secondary to neovascular AMD as determined by decreasing the number of Lucentis injections required during the first 12 months of the study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 neovascular AMD, have received at least 6 prior injections with Lucentis or Avastin and have exhibited one or more of the following:
- •have persisting fluid despite 3 consecutive monthly injections of anti- VEGF, or
- •received 4 prior injections over a 6 month period, or
- •received 8 prior injections over a 12 month period.
- •Subjects must now have the need for further anti-VEGF treatment due to increased fluid or persistent cysts on OCT, or leakage on FA.
- •Subjects 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.
- •Subjects must have signed (and been given) a copy of the informed consent form, and be willing and able to return for scheduled treatment and follow-up examinations for the 3-year duration of the study.
- •Subjects must be at least 50 years of age.
- •Women must be post-menopausal ≥1 year or surgically sterilized, or a pregnancy screen must be performed prior to the study and a reliable form of contraception approved by the investigator must be maintained during the study.
- •Subjects must have best corrected visual acuity of 75 to 25 letters in the study eye and at least 20 letters in the fellow eye.
排除标准
- •CNV due to causes other than AMD, including ocular histoplasmosis syndrome, angioid streaks, multifocal choroiditis, choroidal rupture, or pathologic myopia (spherical equivalent ≥-8 diopters).
- •A globe axial length of <20 mm or >26 mm.
- •Evidence of uncontrolled diabetes as determined by an HbA1c of >6.5% and/or with retinal findings consistent with diabetic retinopathy.
- •Prior or concurrent therapies for age related macular degeneration including submacular surgery, subfoveal thermal laser photocoagulation (with or without photographic evidence), transpupillary thermotherapy (TTT), or ocular photodynamic therapy in the study eye.
- •History of radiation to the head in the region of the study eye.
结局指标
主要结局
Number of Lucentis injections during first 52 weeks
时间窗: 52 weeks
次要结局
- Change in mean VA(52 weeks)
- Loss/gain of letters of BCVA(week 52)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
2 期
INTREPID - IRay Plus Anti-VEGF Treatment For Patients With Wet AMDAMDWet AMDWet Age-Related Macular DegenerationEye DiseasesRetinal DiseasesMacular DegenerationAge-Related Macular DegenerationNCT01016873Oraya Therapeutics, Inc.230
招募中
不适用
Low Concentration Atropine in the Prevention of Myopia in Children.Myopia, ProgressiveNCT05939882Shanghai Eye Disease Prevention and Treatment Center428
已完成
不适用
The Evaluation of the Transcutaneous Electrical Stimulation Medical Device's Safety and Effectiveness in Treating the Patients With Dry Eye DiseaseDry Eye DiseaseNCT05203796Nu Eyne Co., Ltd.24
已完成
不适用
To Evaluate the Safety and Efficacy of a New Device in the Management of Mild to Moderate Atopic Dermatitis in ChildrenAtopic DermatitisNCT00886587Johnson & Johnson Consumer and Personal Products Worldwide82
已完成
不适用
A Study Evaluating the Efficiency and Safety for the VGuard Device in Alzheimer's Disease.Alzheimer Disease (AD)NCT06620640Neuromedical Sp. z o.o.105