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Study to Evaluate Home Vision Testing in Participants Who Receive Ranibizumab (Lucentis®)

6. juni 2019 oppdatert av: Hoffmann-La Roche

Decentralized Pilot Study to Evaluate MyVisionTrack^TM Home Vision Testing in Patients With Diabetic Macular Edema or Neovascular Age-Related Macular Degeneration Currently Receiving Intravitreal Lucentis® Therapy.

This pilot study will evaluate home vision testing using a mobile medical application in participants with diabetic macular edema (DME) or neovascular age-related macula degeneration (nAMD) who receive intravitreal ranibizumab therapy. In the main, decentralized study, participants will be recruited via digital media, advocacy groups, or through their own ophthalmologist. The traditional substudy will evaluate the association between visual acuity and anatomical markers of disease status determined using clinical "gold standard" assessments (certified Early Treatment Diabetic Retinopathy Study [ETDRS] protocol visual acuity and macula optical coherence tomography [OCT]) and the results of home vision testing using the myVisionTrack^TM (mVT) application.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Faktiske)

47

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Utah
      • Salt Lake City, Utah, Forente stater, 84107
        • Rocky Mountain Retina

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Participants who are receiving treatment for DME or nAMD with intravitreal ranibizumab and are being evaluated at intervals of 4-8 weeks.

Beskrivelse

Inclusion Criteria:

  • DME or active nAMD in at least one eye
  • Current treatment with intravitreal ranibizumab therapy, with evaluations planned every 4 to 8 weeks
  • Access to an approved mobile device with a data plan or WiFi internet access

Exclusion Criteria:

  • Any other eye condition causing eye disease that limits vision and cannot be corrected, other than DME or nAMD
  • Dementia or other neurologic or psychological limitation that would prevent the participant from performing regular self-testing of visual function

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Main Study
Decentralized participant recruitment, participant and local ophthalmologist compliance, and use of the mVT mobile medical application in a more geographically diverse, decentralized cohort of participants with DME or nAMD receiving intravitreal ranibizumab therapy as part of standard-of-care treatment.
Annen: Ranibizumab
Ranibizumab administered as part of standard-of-care
Traditional Substudy
Subset of participants enrolled through a single investigator who will determine visual acuity and anatomical markers of disease status using clinical "gold standard" assessments (certified ETDRS protocol visual acuity and macula OCT).
Annen: Ranibizumab
Ranibizumab administered as part of standard-of-care

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Number of "Clicks" on Study Information Advertisements on Participant Advocacy, Digital Media, and Professional Society Websites (Main Study Only)
Tidsramme: Baseline up to 6 months
Baseline up to 6 months
Percentage of Participants Participating at Specified Milestones in the Recruitment/Enrollment Process (Main Study Only)
Tidsramme: Baseline up to 6 months
Baseline up to 6 months
Percentage of Participants Performing Self-Testing Two Times per Week Using the Mobile Medical Application
Tidsramme: Baseline up to 6 months
Baseline up to 6 months
Percentage of Participants Visiting their Ophthalmologist at Least Every 8 Weeks (Main Study Only)
Tidsramme: Baseline up to 6 months
Baseline up to 6 months
Percentage of Office Visits for which Visual Acuity Data Were Provided to Scripps Translational Science Institute (STSI) (Main Study Only)
Tidsramme: Baseline up to 6 months
Baseline up to 6 months
Percentage of Office Visits for which OCT Data Were Provided to STSI (Main Study Only)
Tidsramme: Baseline up to 6 months
Baseline up to 6 months
Degree of Correlation Between mVT Test Results and Certified ETDRS Protocol Visual Acuity (Traditional Substudy Only)
Tidsramme: Baseline up to 6 months
Baseline up to 6 months
Degree of Correlation between mVT Test Results and OCT Characteristics (Traditional Substudy Only)
Tidsramme: Baseline up to 6 months
Baseline up to 6 months

Sekundære resultatmål

Resultatmål
Tidsramme
Association Between mVT Test Results and Routine Visual Acuity Measurements, Measured by Snellen or Other Standard-of-Care Visual Acuity Scores (Main Study Only)
Tidsramme: Baseline up to 6 months
Baseline up to 6 months
Total Number of Participants in the Enrolled Population (Main Study Only)
Tidsramme: Baseline up to 6 months
Baseline up to 6 months
Total Number of Participants in the Confirmed Population (Main Study Only)
Tidsramme: Baseline up to 6 months
Baseline up to 6 months
Differences Between the Participant's and their Ophthalmologist's Assessments of Eligibility (Main Study Only)
Tidsramme: Baseline up to 6 months
Baseline up to 6 months
Percentage of Photographed and Transmitted OCT Images that Are Gradable for Central Subfield Thickness
Tidsramme: Baseline up to 6 months
Baseline up to 6 months
Percentage of Participants Downloading the mVT Application who Require Assistance via Human Interaction from the Help Lines
Tidsramme: Baseline
Baseline
Number of Support Tickets Needed for Technician/Coordinator Interactions with the Participant to Download the mVT Application
Tidsramme: Baseline
Baseline
Total Support Time as an Average per Participant Needed for Technician/Coordinator Interactions with the Participant to Download the mVT Application
Tidsramme: Baseline
Baseline
Number of Additional Support (Calls/Interactions) Required by Participants
Tidsramme: Baseline up to 6 months
Baseline up to 6 months
Number of Critical Security Issues which May Require Reporting
Tidsramme: Baseline up to 6 months
Baseline up to 6 months
Number of Losses of Participant Data Due to Technical Issues
Tidsramme: Baseline up to 6 months
Baseline up to 6 months
Number of Data Processing Issues Occurring During the Study that Are Recoverable but Require Specific Effort, Indicating a Technical Problem
Tidsramme: Baseline up to 6 months
Baseline up to 6 months
Score of Participants Survey on Opinions Regarding Self-Monitoring
Tidsramme: At 1 week and 3 months after enrollment, at study completion/participant withdrawal (up to 6 months)
At 1 week and 3 months after enrollment, at study completion/participant withdrawal (up to 6 months)
Percentages of Substudy OCT Images (Photographs of the OCT Taken Using a Mobile Device), that Are Readable for Qualitative Assessment, Readable for Quantitative Assessment, or Indeterminate (Traditional Substudy Only)
Tidsramme: Baseline up to 6 months
Baseline up to 6 months
Percentage of Actual Substudy Downloaded OCT Images that Are Readable for the Presence of Cysts, Sub Retinal Fluid, and Pigment Epithelial Detachment, or Indeterminate (Traditional Substudy Only)
Tidsramme: Baseline up to 6 months
Baseline up to 6 months

Samarbeidspartnere og etterforskere

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

Sponsor

Hoffmann-La Roche

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 (Faktiske)

20. april 2015

Primær fullføring (Faktiske)

25. august 2016

Studiet fullført (Faktiske)

25. august 2016

Datoer for studieregistrering

Først innsendt

14. april 2015

Først innsendt som oppfylte QC-kriteriene

14. april 2015

Først lagt ut (Anslag)

17. april 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. juni 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. juni 2019

Sist bekreftet

1. juni 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • GE29720

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