Skip to main content
OpenTrials
Completed

NCT Number: NCT02420132

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Macular Edema Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rocky Mountain Retina

Salt Lake City, Utah, 84107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ranibizumab

Other

Ranibizumab administered as part of standard-of-care

Primary outcomes

  1. Number of "Clicks" on Study Information Advertisements on Participant Advocacy, Digital Media, and Professional Society Websites (Main Study Only)

    Time frame: Baseline up to 6 months

  2. Percentage of Participants Participating at Specified Milestones in the Recruitment/Enrollment Process (Main Study Only)

    Time frame: Baseline up to 6 months

  3. Percentage of Participants Performing Self-Testing Two Times per Week Using the Mobile Medical Application

    Time frame: Baseline up to 6 months

  4. Percentage of Participants Visiting their Ophthalmologist at Least Every 8 Weeks (Main Study Only)

    Time frame: Baseline up to 6 months

  5. Percentage of Office Visits for which Visual Acuity Data Were Provided to Scripps Translational Science Institute (STSI) (Main Study Only)

    Time frame: Baseline up to 6 months

  6. Percentage of Office Visits for which OCT Data Were Provided to STSI (Main Study Only)

    Time frame: Baseline up to 6 months

  7. Degree of Correlation Between mVT Test Results and Certified ETDRS Protocol Visual Acuity (Traditional Substudy Only)

    Time frame: Baseline up to 6 months

  8. Degree of Correlation between mVT Test Results and OCT Characteristics (Traditional Substudy Only)

    Time frame: Baseline up to 6 months

Secondary outcomes

  1. Association Between mVT Test Results and Routine Visual Acuity Measurements, Measured by Snellen or Other Standard-of-Care Visual Acuity Scores (Main Study Only)

    Time frame: Baseline up to 6 months

  2. Total Number of Participants in the Enrolled Population (Main Study Only)

    Time frame: Baseline up to 6 months

  3. Total Number of Participants in the Confirmed Population (Main Study Only)

    Time frame: Baseline up to 6 months

  4. Differences Between the Participant's and their Ophthalmologist's Assessments of Eligibility (Main Study Only)

    Time frame: Baseline up to 6 months

  5. Percentage of Photographed and Transmitted OCT Images that Are Gradable for Central Subfield Thickness

    Time frame: Baseline up to 6 months

  6. Percentage of Participants Downloading the mVT Application who Require Assistance via Human Interaction from the Help Lines

    Time frame: Baseline

  7. Number of Support Tickets Needed for Technician/Coordinator Interactions with the Participant to Download the mVT Application

    Time frame: Baseline

  8. Total Support Time as an Average per Participant Needed for Technician/Coordinator Interactions with the Participant to Download the mVT Application

    Time frame: Baseline

  9. Number of Additional Support (Calls/Interactions) Required by Participants

    Time frame: Baseline up to 6 months

  10. Number of Critical Security Issues which May Require Reporting

    Time frame: Baseline up to 6 months

  11. Number of Losses of Participant Data Due to Technical Issues

    Time frame: Baseline up to 6 months

  12. Number of Data Processing Issues Occurring During the Study that Are Recoverable but Require Specific Effort, Indicating a Technical Problem

    Time frame: Baseline up to 6 months

  13. Score of Participants Survey on Opinions Regarding Self-Monitoring

    Time frame: At 1 week and 3 months after enrollment, at study completion/participant withdrawal (up to 6 months)

  14. 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)

    Time frame: Baseline up to 6 months

  15. 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)

    Time frame: Baseline up to 6 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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.

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 17, 2015
Registry last updated
Jun 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.