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

16. juli 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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:

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1520

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

55 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: 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 indgriben: Standard care alone (control) arm
Standard care instruction per clinic routine for home vision monitoring to detect progression of AMD and routine eye exams

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Notal Vision Ltd.

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2010

Primær færdiggørelse (Faktiske)

1. oktober 2013

Studieafslutning (Faktiske)

1. december 2013

Datoer for studieregistrering

Først indsendt

12. april 2010

Først indsendt, der opfyldte QC-kriterier

13. april 2010

Først opslået (Skøn)

14. april 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. juli 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juli 2019

Sidst verificeret

1. juli 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ForeseeHome AREDS2

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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