A Clinical Trial to Assess the Impact of Home Monitoring to Decrease the Treatment Burden for Neovascular Macular Degeneration (the LIBERTY Study).
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Best corrected visual acuity
研究概览
简要总结
A study to use in home technology to reduce the burden of in office visits and injections.
详细描述
Without frequent measurement of vision to monitor disease progression some people may be under-treated, while others over-treated. Under-treatment can lead to severe and irreversible disease progression and associated loss of vision. Over-treatment is expensive, uncomfortable and potentially increases the risk of complications. A self-monitoring device such as DigiSight can help subjects keep close control of their treatment, but alleviate the burden of in office monitoring visits. A decreased number of office visits in combination with the home self-monitoring may provide an effective alternative dosing regimen, allowing the physician and subject to closely track the disease progression and treatment effect without the demands of monthly or frequent visits to the office.
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
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study
- •Age > 50 years
- •Choroidal neovascular membrane (CNV) secondary to AMD, as confirmed by the patient's medical history and a documented diagnosis of CNV
- •The study eye must have received at least 3 anti-Vascular endothelial growth factor (VEGF) treatments prior to the screening visit, with at least 2 anti-VEGF treatments over the preceding 3 months.
- •Best-corrected visual acuity (BCVA) of 20/32 to 20/200 Snellen equivalent in the study eye
- •Noted presence of intra- or sub-retinal fluid on OCT in the study eye
- •Adequate pupillary dilation to permit thorough ocular examination and testing in both eyes
- •Proficiency in using the DigiSight SightBook™ mobile vision assessment tool on study-supplied Apple iPad or iPod device
排除标准
- •CNV in the study eye due to any reason other than AMD
- •Active uncontrolled glaucoma
- •Had any intraocular surgeries in the study eye within 3 months of enrollment or are known or likely candidates for intraocular surgery (including cataract surgery) in the study eye within 1 year of enrollment
- •Acute or chronic ocular or periocular infection in the study eye, uveitis or ocular inflammation in the study eye
- •Received Photo Dynamic Therapy (PDT) in the study eye within 60 days, or laser photocoagulation within 14 days prior to screening
- •Currently using any periocular or intravitreal steroids within 3 months prior to screening (study eye)
- •Unstable or severe cardiovascular disease, e.g., congestive heart failure (New York Heart Association Functional class III/IV), myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina, or critical limb ischemia
- •Poorly controlled diabetes
- •Cerebrovascular disease within 12 months prior to Screening
- •Dementia or neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease)
- •Received any investigational product within 30 days prior to Screening
- •Inability to properly use the SightBook™ app
研究组 & 干预措施
Lucentis every 4 weeks
Lucentis 0.5mg administered intravitreally every four weeks for 12 months
干预措施: Lucentis every 4 weeks (Drug)
Lucentis every 12 weeks
Lucentis 0.5mg administered intravitreally every 12 weeks
干预措施: Lucentis every 12 weeks (Drug)
Treat and extend
Lucentis 0.5mg will be administered on an as needed basis after a loading dose using a treatment extending protocol and home monitoring.
干预措施: Lucentis (Treat and extend) (Drug)
结局指标
主要结局
Best corrected visual acuity
时间窗: 12 months
Best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the Early Treatment Diabetic Retinoptahy Study (ETDRS) eye chart at a starting test distance of 4 meters, at Months 3, 6, 9 and 12
次要结局
- Central foveal thickness(12 months)