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.
Study Type
OBSERVATIONAL
Enrollment
47
Ranibizumab administered as part of standard-of-care
Rocky Mountain Retina
Salt Lake City, Utah, United States
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
Percentage of Participants Participating at Specified Milestones in the Recruitment/Enrollment Process (Main Study Only)
Time frame: Baseline up to 6 months
Percentage of Participants Performing Self-Testing Two Times per Week Using the Mobile Medical Application
Time frame: Baseline up to 6 months
Percentage of Participants Visiting their Ophthalmologist at Least Every 8 Weeks (Main Study Only)
Time frame: 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)
Time frame: Baseline up to 6 months
Percentage of Office Visits for which OCT Data Were Provided to STSI (Main Study Only)
Time frame: Baseline up to 6 months
Degree of Correlation Between mVT Test Results and Certified ETDRS Protocol Visual Acuity (Traditional Substudy Only)
Time frame: Baseline up to 6 months
Degree of Correlation between mVT Test Results and OCT Characteristics (Traditional Substudy Only)
Time frame: Baseline up to 6 months
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
Total Number of Participants in the Enrolled Population (Main Study Only)
Time frame: Baseline up to 6 months
Total Number of Participants in the Confirmed Population (Main Study Only)
Time frame: Baseline up to 6 months
Differences Between the Participant's and their Ophthalmologist's Assessments of Eligibility (Main Study Only)
Time frame: Baseline up to 6 months
Percentage of Photographed and Transmitted OCT Images that Are Gradable for Central Subfield Thickness
Time frame: Baseline up to 6 months
Percentage of Participants Downloading the mVT Application who Require Assistance via Human Interaction from the Help Lines
Time frame: Baseline
Number of Support Tickets Needed for Technician/Coordinator Interactions with the Participant to Download the mVT Application
Time frame: Baseline
Total Support Time as an Average per Participant Needed for Technician/Coordinator Interactions with the Participant to Download the mVT Application
Time frame: Baseline
Number of Additional Support (Calls/Interactions) Required by Participants
Time frame: Baseline up to 6 months
Number of Critical Security Issues which May Require Reporting
Time frame: Baseline up to 6 months
Number of Losses of Participant Data Due to Technical Issues
Time frame: 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
Time frame: Baseline up to 6 months
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)
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
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
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