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HOme Vision Monitoring in AREDS2 for Progression to Neovascular AMD Using the ForeseeHome Device (AREDS)

16. juli 2019 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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:

Studietype

Intervensjonell

Registrering (Faktiske)

1520

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Arkansas
      • Little Rock, Arkansas, Forente stater, 72205
        • Jones Eye Institute - UAMS
    • California
      • La Jolla, California, Forente stater, 92093
        • Shiley Eye Center - UCSD
      • Loma Linda, California, Forente stater, 92354
        • Loma Linda Univ.
      • Sacramento, California, Forente stater, 95817
        • Univ. of California, Davis
    • Colorado
      • Denver, Colorado, Forente stater, 80230
        • Colorado Retina Assoc.
      • Louisville, Colorado, Forente stater, 80027
        • Eldorado Retina Associates
    • Connecticut
      • New Haven, Connecticut, Forente stater
        • Yale Univ. Eye Center
    • Florida
      • Jacksonville, Florida, Forente stater, 32209
        • Univ. of Florida Health Science Center
      • Miami, Florida, Forente stater, 33136
        • Bascom Palmer Eye Institute
      • Sarasota, Florida, Forente stater, 34239
        • Sarasota Retina Institute
    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
        • Emory Univ. Eye Center
      • Decatur, Georgia, Forente stater, 30030
        • Georgia Retina, P.C.
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40509
        • Retina Associates of Kentucky
    • Maryland
      • Baltimore, Maryland, Forente stater, 21237
        • Elman Retina Group, PA
      • Baltimore, Maryland, Forente stater, 21287
        • Wilmer Eye Institute
      • Chevy Chase, Maryland, Forente stater, 20815
        • Retina Group of Washington
    • Massachusetts
      • Boston, Massachusetts, Forente stater
        • Ophthalmic Cons. of Boston
    • Michigan
      • Detroit, Michigan, Forente stater, 48201
        • Kresge Eye Institute
      • Grand Rapids, Michigan, Forente stater, 49546
        • Vision Research Foundation
      • Royal Oak, Michigan, Forente stater, 48073
        • Vision Research Foundation
      • Traverse City, Michigan, Forente stater, 49684
        • Vision Research Foundation
    • New Jersey
      • Lawrenceville, New Jersey, Forente stater
        • Delaware Valley Retina Associates
    • New York
      • Slingerlands, New York, Forente stater, 12159
        • Retina Research Foundation
    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28210
        • Charlotte Eye Ear Nose and Throat Assoc
      • Durham, North Carolina, Forente stater, 27710
        • Duke Univ.
    • Ohio
      • Cleveland, Ohio, Forente stater, 44106
        • Case Western Reserve Univ.
      • Cleveland, Ohio, Forente stater, 44122
        • Retina Assoc. of Cleveland
    • Pennsylvania
      • Camp Hill, Pennsylvania, Forente stater, 17011
        • Pennsylvania Retina Specialists, P.C.
      • Hershey, Pennsylvania, Forente stater, 17033
        • Penn State M.S. Hershey Med Ctr
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Scheie Eye Institute
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • UPMC Eye Center
    • Tennessee
      • Memphis, Tennessee, Forente stater, 38103
        • Univ. of Tennessee HSC
    • Texas
      • Dallas, Texas, Forente stater, 75231
        • Texas Retina Associates
      • Houston, Texas, Forente stater, 77030
        • Retina Consult. of Houston
      • Lubbock, Texas, Forente stater, 79410
        • Texas Retina Associates
    • Utah
      • Salt Lake City, Utah, Forente stater, 84132
        • John Moran Eye Center, Univ. of Utah
    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53705
        • Univ. of Wisconsin
      • Milwaukee, Wisconsin, Forente stater, 53226
        • Medical College of Wisconsin

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

55 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: 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
Diagnostisk test: ForeseeHome AMD Monitoring Device
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
Ingen inngripen: Standard care alone (control) arm
Standard care instruction per clinic routine for home vision monitoring to detect progression of AMD and routine eye exams

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Primary Outcome: Change in Visual Acuity (LogMAR Letters) From Baseline to Detection of Choroidal Neovascularization
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Secondary Outcome: Patients Who Maintained 20/40 or Better Vision at Time of CNV Detection
Tidsramme: 2 years
Percent of patients who maintained 20/40 or better vision at the time of CNV detection in each study arm
2 years
Secondary Outcome: Lesion Size (Total Lesion Area) at Time of Confirmed Progression to CNV
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Notal Vision Ltd.

Etterforskere

  • Studiestol: Emily Chew, MD, National Eye Institute (NEI)

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2010

Primær fullføring (Faktiske)

1. oktober 2013

Studiet fullført (Faktiske)

1. desember 2013

Datoer for studieregistrering

Først innsendt

12. april 2010

Først innsendt som oppfylte QC-kriteriene

13. april 2010

Først lagt ut (Anslag)

14. april 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. juli 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. juli 2019

Sist bekreftet

1. juli 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ForeseeHome AREDS2

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

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