NCT02420132

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

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 47 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Ranibizumab	Ranibizumab administered as part of standard-of-care

Timeline

• Start date: 2015-04-20
• Primary completion: 2016-08-25
• Completion: 2016-08-25
• First posted: 2015-04-17
• Last updated: 2019-06-10

Locations

1 site across 1 country: United States