Clinical trial NCT02420132: Study to Evaluate Home Vision Testing in Participants Who Receive Ranibizumab (Lucentis®)
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Edema
Macular Degeneration
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-04-17
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who are receiving treatment for DME or nAMD with intravitreal ranibizumab and are being evaluated at intervals of 4-8 weeks.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of "Clicks" on Study Information Advertisements on Participant Advocacy, Digital Media, and Professional Society Websites (Main Study Only)
timeFrame: Baseline up to 6 months
measure: Percentage of Participants Participating at Specified Milestones in the Recruitment/Enrollment Process (Main Study Only)
timeFrame: Baseline up to 6 months
measure: Percentage of Participants Performing Self-Testing Two Times per Week Using the Mobile Medical Application
timeFrame: Baseline up to 6 months
measure: Percentage of Participants Visiting their Ophthalmologist at Least Every 8 Weeks (Main Study Only)
timeFrame: Baseline up to 6 months
measure: Percentage of Office Visits for which Visual Acuity Data Were Provided to Scripps Translational Science Institute (STSI) (Main Study Only)
timeFrame: Baseline up to 6 months
measure: Percentage of Office Visits for which OCT Data Were Provided to STSI (Main Study Only)
timeFrame: Baseline up to 6 months
measure: Degree of Correlation Between mVT Test Results and Certified ETDRS Protocol Visual Acuity (Traditional Substudy Only)
timeFrame: Baseline up to 6 months
measure: Degree of Correlation between mVT Test Results and OCT Characteristics (Traditional Substudy Only)
timeFrame: Baseline up to 6 months
Secondary outcomes:
measure: Association Between mVT Test Results and Routine Visual Acuity Measurements, Measured by Snellen or Other Standard-of-Care Visual Acuity Scores (Main Study Only)
timeFrame: Baseline up to 6 months
measure: Total Number of Participants in the Enrolled Population (Main Study Only)
timeFrame: Baseline up to 6 months
measure: Total Number of Participants in the Confirmed Population (Main Study Only)
timeFrame: Baseline up to 6 months
measure: Differences Between the Participant's and their Ophthalmologist's Assessments of Eligibility (Main Study Only)
timeFrame: Baseline up to 6 months
measure: Percentage of Photographed and Transmitted OCT Images that Are Gradable for Central Subfield Thickness
timeFrame: Baseline up to 6 months
measure: Percentage of Participants Downloading the mVT Application who Require Assistance via Human Interaction from the Help Lines
timeFrame: Baseline
measure: Number of Support Tickets Needed for Technician/Coordinator Interactions with the Participant to Download the mVT Application
timeFrame: Baseline
measure: Total Support Time as an Average per Participant Needed for Technician/Coordinator Interactions with the Participant to Download the mVT Application
timeFrame: Baseline
measure: Number of Additional Support (Calls/Interactions) Required by Participants
timeFrame: Baseline up to 6 months
measure: Number of Critical Security Issues which May Require Reporting
timeFrame: Baseline up to 6 months
measure: Number of Losses of Participant Data Due to Technical Issues
timeFrame: Baseline up to 6 months
measure: Number of Data Processing Issues Occurring During the Study that Are Recoverable but Require Specific Effort, Indicating a Technical Problem
timeFrame: Baseline up to 6 months
measure: Score of Participants Survey on Opinions Regarding Self-Monitoring
timeFrame: At 1 week and 3 months after enrollment, at study completion/participant withdrawal (up to 6 months)
measure: 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)
timeFrame: Baseline up to 6 months
measure: 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)
timeFrame: Baseline up to 6 months
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Rocky Mountain Retina
state: Utah
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: