HOme Vision Monitoring in AREDS2 for Progression to Neovascular AMD Using the ForeseeHome Device (AREDS)
16 juli 2019 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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:
Studietyp
Interventionell
Inskrivning (Faktisk)
1520
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Arkansas
-
Little Rock, Arkansas, Förenta staterna, 72205
- Jones Eye Institute - UAMS
-
-
California
-
La Jolla, California, Förenta staterna, 92093
- Shiley Eye Center - UCSD
-
Loma Linda, California, Förenta staterna, 92354
- Loma Linda Univ.
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Sacramento, California, Förenta staterna, 95817
- Univ. of California, Davis
-
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Colorado
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Denver, Colorado, Förenta staterna, 80230
- Colorado Retina Assoc.
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Louisville, Colorado, Förenta staterna, 80027
- Eldorado Retina Associates
-
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Connecticut
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New Haven, Connecticut, Förenta staterna
- Yale Univ. Eye Center
-
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Florida
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Jacksonville, Florida, Förenta staterna, 32209
- Univ. of Florida Health Science Center
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Miami, Florida, Förenta staterna, 33136
- Bascom Palmer Eye Institute
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Sarasota, Florida, Förenta staterna, 34239
- Sarasota Retina Institute
-
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Georgia
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Atlanta, Georgia, Förenta staterna, 30322
- Emory Univ. Eye Center
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Decatur, Georgia, Förenta staterna, 30030
- Georgia Retina, P.C.
-
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Kentucky
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Lexington, Kentucky, Förenta staterna, 40509
- Retina Associates of Kentucky
-
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Maryland
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Baltimore, Maryland, Förenta staterna, 21237
- Elman Retina Group, PA
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Baltimore, Maryland, Förenta staterna, 21287
- Wilmer Eye Institute
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Chevy Chase, Maryland, Förenta staterna, 20815
- Retina Group of Washington
-
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Massachusetts
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Boston, Massachusetts, Förenta staterna
- Ophthalmic Cons. of Boston
-
-
Michigan
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Detroit, Michigan, Förenta staterna, 48201
- Kresge Eye Institute
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Grand Rapids, Michigan, Förenta staterna, 49546
- Vision Research Foundation
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Royal Oak, Michigan, Förenta staterna, 48073
- Vision Research Foundation
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Traverse City, Michigan, Förenta staterna, 49684
- Vision Research Foundation
-
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New Jersey
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Lawrenceville, New Jersey, Förenta staterna
- Delaware Valley Retina Associates
-
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New York
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Slingerlands, New York, Förenta staterna, 12159
- Retina Research Foundation
-
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North Carolina
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Charlotte, North Carolina, Förenta staterna, 28210
- Charlotte Eye Ear Nose and Throat Assoc
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Durham, North Carolina, Förenta staterna, 27710
- Duke Univ.
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Ohio
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Cleveland, Ohio, Förenta staterna, 44106
- Case Western Reserve Univ.
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Cleveland, Ohio, Förenta staterna, 44122
- Retina Assoc. of Cleveland
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Pennsylvania
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Camp Hill, Pennsylvania, Förenta staterna, 17011
- Pennsylvania Retina Specialists, P.C.
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Hershey, Pennsylvania, Förenta staterna, 17033
- Penn State M.S. Hershey Med Ctr
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Philadelphia, Pennsylvania, Förenta staterna, 19104
- Scheie Eye Institute
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Pittsburgh, Pennsylvania, Förenta staterna, 15213
- UPMC Eye Center
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Tennessee
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Memphis, Tennessee, Förenta staterna, 38103
- Univ. of Tennessee HSC
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Texas
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Dallas, Texas, Förenta staterna, 75231
- Texas Retina Associates
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Houston, Texas, Förenta staterna, 77030
- Retina Consult. of Houston
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Lubbock, Texas, Förenta staterna, 79410
- Texas Retina Associates
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Utah
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Salt Lake City, Utah, Förenta staterna, 84132
- John Moran Eye Center, Univ. of Utah
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Wisconsin
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Madison, Wisconsin, Förenta staterna, 53705
- Univ. of Wisconsin
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Milwaukee, Wisconsin, Förenta staterna, 53226
- Medical College of Wisconsin
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
55 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: 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
|
|
Inget ingripande: Standard care alone (control) arm
Standard care instruction per clinic routine for home vision monitoring to detect progression of AMD and routine eye exams
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Primary Outcome: Change in Visual Acuity (LogMAR Letters) From Baseline to Detection of Choroidal Neovascularization
Tidsram: 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.
|
2 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Secondary Outcome: Patients Who Maintained 20/40 or Better Vision at Time of CNV Detection
Tidsram: 2 years
|
Percent of patients who maintained 20/40 or better vision at the time of CNV detection in each study arm
|
2 years
|
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Secondary Outcome: Lesion Size (Total Lesion Area) at Time of Confirmed Progression to CNV
Tidsram: 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.
|
2 years
|
|
Secondary Outcome: Lesion Size (CNV Area) at Time of Confirmed Progression to CNV
Tidsram: 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.
|
2 years
|
|
Secondary Outcome: Lesion Size (Fluid Area) at Time of Confirmed Progression to CNV
Tidsram: 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.
|
2 years
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studiestol: Emily Chew, MD, National Eye Institute (NEI)
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2010
Primärt slutförande (Faktisk)
1 oktober 2013
Avslutad studie (Faktisk)
1 december 2013
Studieregistreringsdatum
Först inskickad
12 april 2010
Först inskickad som uppfyllde QC-kriterierna
13 april 2010
Första postat (Uppskatta)
14 april 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
30 juli 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 juli 2019
Senast verifierad
1 juli 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ForeseeHome AREDS2
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Ja
produkt tillverkad i och exporterad från U.S.A.
Nej
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