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

Macular Degeneration Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02420132
• Other study ID #: GE29720
• Status: Completed
• Start date: April 20, 2015
• Est. completion date: August 25, 2016

Study information

• Verified date: June 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: August 25, 2016
• Est. primary completion date: August 25, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Macular Edema

Intervention

Other:
• Ranibizumab
Ranibizumab administered as part of standard-of-care

Locations

Country	Name	City	State
United States	Rocky Mountain Retina	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of "Clicks" on Study Information Advertisements on Participant Advocacy, Digital Media, and Professional Society Websites (Main Study Only)		Baseline up to 6 months
Primary	Percentage of Participants Participating at Specified Milestones in the Recruitment/Enrollment Process (Main Study Only)		Baseline up to 6 months
Primary	Percentage of Participants Performing Self-Testing Two Times per Week Using the Mobile Medical Application		Baseline up to 6 months
Primary	Percentage of Participants Visiting their Ophthalmologist at Least Every 8 Weeks (Main Study Only)		Baseline up to 6 months
Primary	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
Primary	Percentage of Office Visits for which OCT Data Were Provided to STSI (Main Study Only)		Baseline up to 6 months
Primary	Degree of Correlation Between mVT Test Results and Certified ETDRS Protocol Visual Acuity (Traditional Substudy Only)		Baseline up to 6 months
Primary	Degree of Correlation between mVT Test Results and OCT Characteristics (Traditional Substudy Only)		Baseline up to 6 months
Secondary	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
Secondary	Total Number of Participants in the Enrolled Population (Main Study Only)		Baseline up to 6 months
Secondary	Total Number of Participants in the Confirmed Population (Main Study Only)		Baseline up to 6 months
Secondary	Differences Between the Participant's and their Ophthalmologist's Assessments of Eligibility (Main Study Only)		Baseline up to 6 months
Secondary	Percentage of Photographed and Transmitted OCT Images that Are Gradable for Central Subfield Thickness		Baseline up to 6 months
Secondary	Percentage of Participants Downloading the mVT Application who Require Assistance via Human Interaction from the Help Lines		Baseline
Secondary	Number of Support Tickets Needed for Technician/Coordinator Interactions with the Participant to Download the mVT Application		Baseline
Secondary	Total Support Time as an Average per Participant Needed for Technician/Coordinator Interactions with the Participant to Download the mVT Application		Baseline
Secondary	Number of Additional Support (Calls/Interactions) Required by Participants		Baseline up to 6 months
Secondary	Number of Critical Security Issues which May Require Reporting		Baseline up to 6 months
Secondary	Number of Losses of Participant Data Due to Technical Issues		Baseline up to 6 months
Secondary	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
Secondary	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)
Secondary	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
Secondary	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