NCT01542866已完成不适用
A 16 Week Evaluation of the Novartis Health Management Tool in Assessing Self-test Visual Function in Patients With AMD Treated With Ranibizumab
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 24
- 主要终点
- Identification of clinically relevant worsening of visual function in the home self testing mVT scores
研究概览
简要总结
This is a prospective pilot study to evaluate the usability and applicability of a self monitoring test of visual function with the handheld Health Management Tool (HMT) to remotely monitor neovascular Age Related Macular Degeneration (AMD) to detect a potential change in disease status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CNV secondary to AMD and not other causes in at least one eye identified by the investigator to be eligible for ranibizumab treatment
- •Patients with a BCVA letter score in the study eye is 24 or better using an ETDRS chart measured at 4 meters distance
排除标准
- •Patients with any concurrent ocular condition that may result in visual loss during the study
- •Patients with past (within the prior 6 months) or current use of, or likely need for, systemic medications that are known to be toxic to the lens, retina, or optic nerve
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Home Monitoring Test
Experimental
Health management tool (HMT) for measuring vision impairment
干预措施: Health Management Tool (HMT) (Other)
结局指标
主要结局
Identification of clinically relevant worsening of visual function in the home self testing mVT scores
时间窗: baseline to 16 weeks
Threshold value of handheld Health Management Tool (HMT) for choroidal neovascular AMD diagnosis at baseline
时间窗: 16 weeks
次要结局
- Correlation between the home deterioration signal and the monthly change in the handheld Health Management Tool (HMT) assessments performed during the site visits(after 16 weeks)
- Correlation between absolute values of the handheld Health Management Tool (HMT) and BCVA/ central retinal subfield thickness (CRST)(16 weeks)
- Correlation of diagnosis of choroidal neovascular AMD with BCVA/ central retinal subfield thickness(baseline)
- Patient satisfaction regarding the use of the HMT(16 weeks)
- Patient compliance and reliability of performing the home self testing using the handheld Health Management Tool (HMT)(after 16 weeks)
- Patient compliance with the signs and symptom questionnaire(baseline to 16 weeks)
- Correlation of the handheld Health Management Tool (HMT) home self testing on the days of site visits and the mVT assessments performed during the site visits for absolute values(after 16 weeks)
- Correlation of the monthly changes in handheld Health Management Tool(HMT)to those of BCVA / OCT / Clinical examination(after 16 weeks)
- Correlation of monthly changes observed with thein the investigator judgment (CJ-C) to BCVA / OCT / Clinical examination(baseline to 16 weeks)
研究者
研究点 (24)
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