HOme Vision Monitoring in AREDS2 for Progression to Neovascular AMD Using the ForeseeHome Device (AREDS)
2019년 7월 16일 업데이트: 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.
연구 개요
상세 설명
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:
연구 유형
중재적
등록 (실제)
1520
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Arkansas
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Little Rock, Arkansas, 미국, 72205
- Jones Eye Institute - UAMS
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California
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La Jolla, California, 미국, 92093
- Shiley Eye Center - UCSD
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Loma Linda, California, 미국, 92354
- Loma Linda Univ.
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Sacramento, California, 미국, 95817
- Univ. of California, Davis
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Colorado
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Denver, Colorado, 미국, 80230
- Colorado Retina Assoc.
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Louisville, Colorado, 미국, 80027
- Eldorado Retina Associates
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Connecticut
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New Haven, Connecticut, 미국
- Yale Univ. Eye Center
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Florida
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Jacksonville, Florida, 미국, 32209
- Univ. of Florida Health Science Center
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Miami, Florida, 미국, 33136
- Bascom Palmer Eye Institute
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Sarasota, Florida, 미국, 34239
- Sarasota Retina Institute
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Georgia
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Atlanta, Georgia, 미국, 30322
- Emory Univ. Eye Center
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Decatur, Georgia, 미국, 30030
- Georgia Retina, P.C.
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Kentucky
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Lexington, Kentucky, 미국, 40509
- Retina Associates of Kentucky
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Maryland
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Baltimore, Maryland, 미국, 21237
- Elman Retina Group, PA
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Baltimore, Maryland, 미국, 21287
- Wilmer Eye Institute
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Chevy Chase, Maryland, 미국, 20815
- Retina Group of Washington
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Massachusetts
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Boston, Massachusetts, 미국
- Ophthalmic Cons. of Boston
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Michigan
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Detroit, Michigan, 미국, 48201
- Kresge Eye Institute
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Grand Rapids, Michigan, 미국, 49546
- Vision Research Foundation
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Royal Oak, Michigan, 미국, 48073
- Vision Research Foundation
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Traverse City, Michigan, 미국, 49684
- Vision Research Foundation
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New Jersey
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Lawrenceville, New Jersey, 미국
- Delaware Valley Retina Associates
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New York
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Slingerlands, New York, 미국, 12159
- Retina Research Foundation
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North Carolina
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Charlotte, North Carolina, 미국, 28210
- Charlotte Eye Ear Nose and Throat Assoc
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Durham, North Carolina, 미국, 27710
- Duke Univ.
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Ohio
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Cleveland, Ohio, 미국, 44106
- Case Western Reserve Univ.
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Cleveland, Ohio, 미국, 44122
- Retina Assoc. of Cleveland
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Pennsylvania
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Camp Hill, Pennsylvania, 미국, 17011
- Pennsylvania Retina Specialists, P.C.
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Hershey, Pennsylvania, 미국, 17033
- Penn State M.S. Hershey Med Ctr
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Philadelphia, Pennsylvania, 미국, 19104
- Scheie Eye Institute
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Pittsburgh, Pennsylvania, 미국, 15213
- UPMC Eye Center
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Tennessee
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Memphis, Tennessee, 미국, 38103
- Univ. of Tennessee HSC
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Texas
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Dallas, Texas, 미국, 75231
- Texas Retina Associates
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Houston, Texas, 미국, 77030
- Retina Consult. of Houston
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Lubbock, Texas, 미국, 79410
- Texas Retina Associates
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Utah
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Salt Lake City, Utah, 미국, 84132
- John Moran Eye Center, Univ. of Utah
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Wisconsin
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Madison, Wisconsin, 미국, 53705
- Univ. of Wisconsin
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Milwaukee, Wisconsin, 미국, 53226
- Medical College of Wisconsin
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
55년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: 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
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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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간섭 없음: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Primary Outcome: Change in Visual Acuity (LogMAR Letters) From Baseline to Detection of Choroidal Neovascularization
기간: 2 years
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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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Secondary Outcome: Patients Who Maintained 20/40 or Better Vision at Time of CNV Detection
기간: 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
기간: 2 years
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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
기간: 2 years
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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
기간: 2 years
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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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Emily Chew, MD, National Eye Institute (NEI)
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
유용한 링크
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2010년 5월 1일
기본 완료 (실제)
2013년 10월 1일
연구 완료 (실제)
2013년 12월 1일
연구 등록 날짜
최초 제출
2010년 4월 12일
QC 기준을 충족하는 최초 제출
2010년 4월 13일
처음 게시됨 (추정)
2010년 4월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 7월 30일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 7월 16일
마지막으로 확인됨
2019년 7월 1일
추가 정보
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