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

Completed

Conditions studied: Macular Edema, Macular Degeneration

In brief

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.

Key facts

Study ID

NCT02420132

Run by

Hoffmann-La Roche

People needed

47

Starts

2015-04-20

Expected to finish

2016-08-25

Last updated by the study team

2019-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Rocky Mountain Retina — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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