Study to Evaluate Home Vision Testing in Participants Who Receive Ranibizumab (Lucentis®)
| Status: | Completed |
|---|---|
| Conditions: | Ocular, Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/21/2018 |
| Start Date: | April 20, 2015 |
| End Date: | August 25, 2016 |
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.
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.
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.
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
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