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

Roche

Status: Completed

Conditions: Macular Degeneration; Macular Edema

Treatments: Other: Ranibizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT02420132

GE29720

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

47 participants in 2 patient groups

Main Study

Description:

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.

Treatment:

Other: Ranibizumab

Traditional Substudy

Description:

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).

Treatment:

Other: Ranibizumab