HOme Vision Monitoring in AREDS2 for Progression to Neovascular AMD Using the ForeseeHome Device (AREDS)
16 de julio de 2019 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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:
Tipo de estudio
Intervencionista
Inscripción (Actual)
1520
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
- Jones Eye Institute - UAMS
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California
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La Jolla, California, Estados Unidos, 92093
- Shiley Eye Center - UCSD
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Loma Linda, California, Estados Unidos, 92354
- Loma Linda Univ.
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Sacramento, California, Estados Unidos, 95817
- Univ. of California, Davis
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Colorado
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Denver, Colorado, Estados Unidos, 80230
- Colorado Retina Assoc.
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Louisville, Colorado, Estados Unidos, 80027
- Eldorado Retina Associates
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Connecticut
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New Haven, Connecticut, Estados Unidos
- Yale Univ. Eye Center
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Florida
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Jacksonville, Florida, Estados Unidos, 32209
- Univ. of Florida Health Science Center
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Miami, Florida, Estados Unidos, 33136
- Bascom Palmer Eye Institute
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Sarasota, Florida, Estados Unidos, 34239
- Sarasota Retina Institute
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Emory Univ. Eye Center
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Decatur, Georgia, Estados Unidos, 30030
- Georgia Retina, P.C.
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40509
- Retina Associates of Kentucky
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Maryland
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Baltimore, Maryland, Estados Unidos, 21237
- Elman Retina Group, PA
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Baltimore, Maryland, Estados Unidos, 21287
- Wilmer Eye Institute
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Chevy Chase, Maryland, Estados Unidos, 20815
- Retina Group of Washington
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Massachusetts
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Boston, Massachusetts, Estados Unidos
- Ophthalmic Cons. of Boston
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Michigan
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Detroit, Michigan, Estados Unidos, 48201
- Kresge Eye Institute
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Grand Rapids, Michigan, Estados Unidos, 49546
- Vision Research Foundation
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Royal Oak, Michigan, Estados Unidos, 48073
- Vision Research Foundation
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Traverse City, Michigan, Estados Unidos, 49684
- Vision Research Foundation
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New Jersey
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Lawrenceville, New Jersey, Estados Unidos
- Delaware Valley Retina Associates
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New York
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Slingerlands, New York, Estados Unidos, 12159
- Retina Research Foundation
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28210
- Charlotte Eye Ear Nose and Throat Assoc
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Durham, North Carolina, Estados Unidos, 27710
- Duke Univ.
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Ohio
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Cleveland, Ohio, Estados Unidos, 44106
- Case Western Reserve Univ.
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Cleveland, Ohio, Estados Unidos, 44122
- Retina Assoc. of Cleveland
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Pennsylvania
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Camp Hill, Pennsylvania, Estados Unidos, 17011
- Pennsylvania Retina Specialists, P.C.
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Hershey, Pennsylvania, Estados Unidos, 17033
- Penn State M.S. Hershey Med Ctr
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Scheie Eye Institute
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- UPMC Eye Center
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38103
- Univ. of Tennessee HSC
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Texas
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Dallas, Texas, Estados Unidos, 75231
- Texas Retina Associates
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Houston, Texas, Estados Unidos, 77030
- Retina Consult. of Houston
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Lubbock, Texas, Estados Unidos, 79410
- Texas Retina Associates
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Utah
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Salt Lake City, Utah, Estados Unidos, 84132
- John Moran Eye Center, Univ. of Utah
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53705
- Univ. of Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Medical College of Wisconsin
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
55 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: 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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Sin intervención: Standard care alone (control) arm
Standard care instruction per clinic routine for home vision monitoring to detect progression of AMD and routine eye exams
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Primary Outcome: Change in Visual Acuity (LogMAR Letters) From Baseline to Detection of Choroidal Neovascularization
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Secondary Outcome: Patients Who Maintained 20/40 or Better Vision at Time of CNV Detection
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Secondary Outcome: Lesion Size (CNV Area) at Time of Confirmed Progression to CNV
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Emily Chew, MD, National Eye Institute (NEI)
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de mayo de 2010
Finalización primaria (Actual)
1 de octubre de 2013
Finalización del estudio (Actual)
1 de diciembre de 2013
Fechas de registro del estudio
Enviado por primera vez
12 de abril de 2010
Primero enviado que cumplió con los criterios de control de calidad
13 de abril de 2010
Publicado por primera vez (Estimar)
14 de abril de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
30 de julio de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
16 de julio de 2019
Última verificación
1 de julio de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ForeseeHome AREDS2
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
producto fabricado y exportado desde los EE. UU.
No
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