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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Macular Edema, Macular Degeneration

Intervention / Treatment
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* Other: Ranibizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Main Study<br>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. | Other: Ranibizumab<br>* Ranibizumab administered as part of standard-of-care<br>|
| Traditional Substudy<br>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). | Other: Ranibizumab<br>* Ranibizumab administered as part of standard-of-care<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association Between mVT Test Results and Routine Visual Acuity Measurements, Measured by Snellen or Other Standard-of-Care Visual Acuity Scores (Main Study Only) |  | Baseline up to 6 months | 
| Total Number of Participants in the Enrolled Population (Main Study Only) |  | Baseline up to 6 months | 
| Total Number of Participants in the Confirmed Population (Main Study Only) |  | Baseline up to 6 months | 
| Differences Between the Participant's and their Ophthalmologist's Assessments of Eligibility (Main Study Only) |  | Baseline up to 6 months | 
| Percentage of Photographed and Transmitted OCT Images that Are Gradable for Central Subfield Thickness |  | Baseline up to 6 months | 
| Percentage of Participants Downloading the mVT Application who Require Assistance via Human Interaction from the Help Lines |  | Baseline | 
| Number of Support Tickets Needed for Technician/Coordinator Interactions with the Participant to Download the mVT Application |  | Baseline | 
| Total Support Time as an Average per Participant Needed for Technician/Coordinator Interactions with the Participant to Download the mVT Application |  | Baseline | 
| Number of Additional Support (Calls/Interactions) Required by Participants |  | Baseline up to 6 months | 
| Number of Critical Security Issues which May Require Reporting |  | Baseline up to 6 months | 
| Number of Losses of Participant Data Due to Technical Issues |  | 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 |  | Baseline up to 6 months | 
| Score of Participants Survey on Opinions Regarding Self-Monitoring |  | 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) |  | 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) |  | Baseline up to 6 months |