HOme Vision Monitoring in AREDS2 for Progression to Neovascular AMD Using the ForeseeHome Device (AREDS)
2019年7月16日 更新者：Notal Vision Ltd.
The HOME Study: HOme Vision Monitoring in AREDS2 for Progression to Neovascular AMD Using the ForeseeHome Device - (HOme Monitoring of the Eye)
The overall objective of this two arm randomized clinical trial (RCT) is to determine if home monitoring using the comprehensive visual field and telemedicine solution based on the ForeseeHome device in AREDS2 improves detection of progression to choroidal neovascularization (CNV) when compared with standard care.
研究概览
详细说明
The overall objective of this two arm randomized clinical trial (RCT) is to determine if home monitoring using the comprehensive visual field and telemedicine solution based on the ForeseeHome device in AREDS2 (referred to as the ForeseeHome comprehensive solution) participants at high risk of progression to neovascular AMD improves detection of progression to choroidal neovascularization (CNV) when compared with standard care.
The primary outcome of this study is presenting best corrected visual acuity (BCVA) at the time of CNV diagnosis.
Secondary outcomes include time to confirmed CNV diagnosis, lesion size, lesion location (extrafoveal, juxtafoveal, or subfoveal), lesion type (occult without classic, predominantly classic or minimally classic), sensitivity and specificity, and BCVA following three consecutive months of treatment and twelve months after the initial start of CNV treatment with an intravitreal anti-VEGF agent using either ranibizumab or bevacizumab.
Outcomes will be ascertained via the following specific aims:
研究类型
介入性
注册 (实际的)
1520
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Arkansas
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Little Rock、Arkansas、美国、72205
- Jones Eye Institute - UAMS
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California
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La Jolla、California、美国、92093
- Shiley Eye Center - UCSD
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Loma Linda、California、美国、92354
- Loma Linda Univ.
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Sacramento、California、美国、95817
- Univ. of California, Davis
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Colorado
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Denver、Colorado、美国、80230
- Colorado Retina Assoc.
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Louisville、Colorado、美国、80027
- Eldorado Retina Associates
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Connecticut
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New Haven、Connecticut、美国
- Yale Univ. Eye Center
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Florida
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Jacksonville、Florida、美国、32209
- Univ. of Florida Health Science Center
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Miami、Florida、美国、33136
- Bascom Palmer Eye Institute
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Sarasota、Florida、美国、34239
- Sarasota Retina Institute
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Georgia
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Atlanta、Georgia、美国、30322
- Emory Univ. Eye Center
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Decatur、Georgia、美国、30030
- Georgia Retina, P.C.
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Kentucky
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Lexington、Kentucky、美国、40509
- Retina Associates of Kentucky
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Maryland
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Baltimore、Maryland、美国、21237
- Elman Retina Group, PA
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Baltimore、Maryland、美国、21287
- Wilmer Eye Institute
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Chevy Chase、Maryland、美国、20815
- Retina Group of Washington
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Massachusetts
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Boston、Massachusetts、美国
- Ophthalmic Cons. of Boston
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Michigan
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Detroit、Michigan、美国、48201
- Kresge Eye Institute
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Grand Rapids、Michigan、美国、49546
- Vision Research Foundation
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Royal Oak、Michigan、美国、48073
- Vision Research Foundation
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Traverse City、Michigan、美国、49684
- Vision Research Foundation
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New Jersey
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Lawrenceville、New Jersey、美国
- Delaware Valley Retina Associates
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New York
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Slingerlands、New York、美国、12159
- Retina Research Foundation
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North Carolina
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Charlotte、North Carolina、美国、28210
- Charlotte Eye Ear Nose and Throat Assoc
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Durham、North Carolina、美国、27710
- Duke Univ.
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Ohio
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Cleveland、Ohio、美国、44106
- Case Western Reserve Univ.
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Cleveland、Ohio、美国、44122
- Retina Assoc. of Cleveland
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Pennsylvania
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Camp Hill、Pennsylvania、美国、17011
- Pennsylvania Retina Specialists, P.C.
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Hershey、Pennsylvania、美国、17033
- Penn State M.S. Hershey Med Ctr
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Philadelphia、Pennsylvania、美国、19104
- Scheie Eye Institute
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Pittsburgh、Pennsylvania、美国、15213
- UPMC Eye Center
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Tennessee
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Memphis、Tennessee、美国、38103
- Univ. of Tennessee HSC
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Texas
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Dallas、Texas、美国、75231
- Texas Retina Associates
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Houston、Texas、美国、77030
- Retina Consult. of Houston
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Lubbock、Texas、美国、79410
- Texas Retina Associates
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Utah
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Salt Lake City、Utah、美国、84132
- John Moran Eye Center, Univ. of Utah
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Wisconsin
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Madison、Wisconsin、美国、53705
- Univ. of Wisconsin
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Milwaukee、Wisconsin、美国、53226
- Medical College of Wisconsin
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
55年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
INCLUSION CRITERIA:
- Male or female participant between 55 and 90 years of age. Participants must have bilateral large drusen (at least 125 micron), or large drusen in the posterior pole in one eye (study eye) and advanced AMD (neovascular AMD or central geographic atrophy) in the fellow eye as determined by their study ophthalmologist. Likelihood, willingness, and ability to return for multiple visits (potentially within the same month) for at least 2 years.
- Participant must be English speaking and understand and sign the protocol's informed consent document.
- Participant must be able to successfully demonstrate their ability to comprehend instructions and use of the ForeseeHome device (a ForeseeHome device will be available at the clinic for the participant to demonstrate their ability).
- Participant's address to which the ForeseeHome device will be sent, if randomized to the device monitoring arm, must be located in the U.S.A.
- Study eye(s) must have best corrected visual acuity 20/60 or better (at least 54 letters).
- Ocular media sufficient to allow adequate quality fundus photography.
- Participant must be willing to have name and contact information provided to Notal Vision.
- Participant must consent to be examined by the study ophthalmologist when changes in symptoms are detected by the home-device or by standard of care or when unreliable test results occur during the usage period.
- If randomized to the device monitoring arm, participant must agree to take the device with them if staying somewhere else other than their primary residence for 14 days or more.
EXCLUSION CRITERIA:
- Participant has evidence of macular or retinal disorders other than AMD in the study eye(s).
- Participant has known adverse reaction to fluorescein dye or refuses further fluorescein angiograms.
- Participant's eye is receiving (or is expected to receive) an eye examination on a continuing basis by an eye care professional more frequently than every four months
- NonAREDS2 participant currently enrolled in another study that may likely affect adherence with The HOME Study
- Previous retinal or other ocular surgical procedures, the effects of which may now or in the future complicate assessment of the progression of AMD in the study eye.
- Chronic requirement for any systemic or ocular medication administered for other diseases
- Cataract surgery within one month of randomization.
- Participant that has any condition that would make adherence to study follow up procedures for at least one year difficult or unlikely
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：ForeseeHome AMD Monitoring Device
Participants in the device monitoring arm will receive a packed device at home, with instructions to install and connect the device to a modem as well as instructions for daily use of the device in addition to standard care
|
Earlier detection of progression from intermediate dry age-related macular degeneration to CNV between routine eye exams through home diagnostic testing with the ForeseeHome AMD Monitoring device
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无干预：Standard care alone (control) arm
Standard care instruction per clinic routine for home vision monitoring to detect progression of AMD and routine eye exams
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Primary Outcome: Change in Visual Acuity (LogMAR Letters) From Baseline to Detection of Choroidal Neovascularization
大体时间：2 years
|
Mean change in BCVA (logMAR letters) from baseline to the time of confirmed progression to CNV in the ForeseeHome device monitoring group compared to the standard care group.
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2 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Secondary Outcome: Patients Who Maintained 20/40 or Better Vision at Time of CNV Detection
大体时间：2 years
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Percent of patients who maintained 20/40 or better vision at the time of CNV detection in each study arm
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2 years
|
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Secondary Outcome: Lesion Size (Total Lesion Area) at Time of Confirmed Progression to CNV
大体时间：2 years
|
Median lesion size (total lesion area) at time of confirmed progression to CNV as measured on fluorescein angiography (FA) will be compared between the two study arms.
Lesion size was assessed, measured, and reported by optic disc areas, where 1 disc area = 2.54 mm^2.
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2 years
|
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Secondary Outcome: Lesion Size (CNV Area) at Time of Confirmed Progression to CNV
大体时间：2 years
|
Median lesion size (CNV area) at time of confirmed progression to CNV as measured on fluorescein angiography will be compared between the two study arms.
Lesion size was assessed, measured, and reported by optic disc areas, where 1 disc area = 2.54 mm^2.
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2 years
|
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Secondary Outcome: Lesion Size (Fluid Area) at Time of Confirmed Progression to CNV
大体时间：2 years
|
Median lesion size (fluid area) at time of confirmed progression to CNV as measured on fluorescein angiography will be compared between the two study arms.
Lesion size was assessed, measured, and reported by optic disc areas, where 1 disc area = 2.54 mm^2.
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2 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Emily Chew, MD、National Eye Institute (NEI)
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年5月1日
初级完成 (实际的)
2013年10月1日
研究完成 (实际的)
2013年12月1日
研究注册日期
首次提交
2010年4月12日
首先提交符合 QC 标准的
2010年4月13日
首次发布 (估计)
2010年4月14日
研究记录更新
最后更新发布 (实际的)
2019年7月30日
上次提交的符合 QC 标准的更新
2019年7月16日
最后验证
2019年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.