NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT02420132

CompletedN/A

Sponsor: Hoffmann-La Roche

Conditions: Macular Edema, Macular Degeneration

Interventions: Ranibizumab

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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

Locations (1)

Salt Lake City, Utah, United States