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

NCT02420132 | Completed

• 1 other identifier: GE29720
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Edema; Macular Degeneration

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (15)

• 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

Study Arms (2)

Main Study

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

Traditional Substudy

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

Interventions

Ranibizumab OTHER

Ranibizumab administered as part of standard-of-care

Main Study; Traditional Substudy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Rocky Mountain Retina

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Macular Edema; Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: April 17, 2015
• Study Start: April 20, 2015
• Primary Completion: August 25, 2016
• Study Completion: August 25, 2016
• Last Updated: June 10, 2019

Record last verified: 2019-06

Locations

US (1)