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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-20

Study Completion Date

2016-08-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Macular Edema Macular Degeneration

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Main Study

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.

Ranibizumab

Intervention Type OTHER

Ranibizumab administered as part of standard-of-care

Traditional Substudy

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).

Ranibizumab

Intervention Type OTHER

Ranibizumab administered as part of standard-of-care

Interventions

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Ranibizumab

Ranibizumab administered as part of standard-of-care

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No