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

6 juni 2019 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Faktisk)

47

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Utah
      • Salt Lake City, Utah, Förenta staterna, 84107
        • Rocky Mountain Retina

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

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / 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.
Övrig: 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).
Övrig: Ranibizumab
Ranibizumab administered as part of standard-of-care

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Number of "Clicks" on Study Information Advertisements on Participant Advocacy, Digital Media, and Professional Society Websites (Main Study Only)
Tidsram: 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)
Tidsram: 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
Tidsram: Baseline up to 6 months
Baseline up to 6 months
Percentage of Participants Visiting their Ophthalmologist at Least Every 8 Weeks (Main Study Only)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: Baseline up to 6 months
Baseline up to 6 months
Degree of Correlation between mVT Test Results and OCT Characteristics (Traditional Substudy Only)
Tidsram: Baseline up to 6 months
Baseline up to 6 months

Sekundära resultatmått

Resultatmått
Tidsram
Association Between mVT Test Results and Routine Visual Acuity Measurements, Measured by Snellen or Other Standard-of-Care Visual Acuity Scores (Main Study Only)
Tidsram: Baseline up to 6 months
Baseline up to 6 months
Total Number of Participants in the Enrolled Population (Main Study Only)
Tidsram: Baseline up to 6 months
Baseline up to 6 months
Total Number of Participants in the Confirmed Population (Main Study Only)
Tidsram: 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)
Tidsram: Baseline up to 6 months
Baseline up to 6 months
Percentage of Photographed and Transmitted OCT Images that Are Gradable for Central Subfield Thickness
Tidsram: 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
Tidsram: Baseline
Baseline
Number of Support Tickets Needed for Technician/Coordinator Interactions with the Participant to Download the mVT Application
Tidsram: Baseline
Baseline
Total Support Time as an Average per Participant Needed for Technician/Coordinator Interactions with the Participant to Download the mVT Application
Tidsram: Baseline
Baseline
Number of Additional Support (Calls/Interactions) Required by Participants
Tidsram: Baseline up to 6 months
Baseline up to 6 months
Number of Critical Security Issues which May Require Reporting
Tidsram: Baseline up to 6 months
Baseline up to 6 months
Number of Losses of Participant Data Due to Technical Issues
Tidsram: 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
Tidsram: Baseline up to 6 months
Baseline up to 6 months
Score of Participants Survey on Opinions Regarding Self-Monitoring
Tidsram: 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)
Tidsram: 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)
Tidsram: Baseline up to 6 months
Baseline up to 6 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Hoffmann-La Roche

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 (Faktisk)

20 april 2015

Primärt slutförande (Faktisk)

25 augusti 2016

Avslutad studie (Faktisk)

25 augusti 2016

Studieregistreringsdatum

Först inskickad

14 april 2015

Först inskickad som uppfyllde QC-kriterierna

14 april 2015

Första postat (Uppskatta)

17 april 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 juni 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 juni 2019

Senast verifierad

1 juni 2019

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • GE29720

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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