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NCT01337414 · ClinicalTrials.gov registry record · NA
Tools to Optimize Patient Presentation After Onset of Exudative Age-Related Macular Degeneration (AMD)
A NA study, sponsored by Johns Hopkins University.
- Terminated
- Registry status
- NA
- Development phase
- 324
- Enrollment target
NCT01337414: Clinical Trial NA study, sponsored by Johns Hopkins University.
NCT01337414 is a NA study that was terminated before completion, run by Johns Hopkins University. The registered enrollment target is 324 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01337414, a NA study, was terminated before completion, sponsored by Johns Hopkins University.
- TERMINATED
- Registry status
- NA
- Development phase
- 324 participants
- Enrollment target
Study Summary
Exudative age-related macular degeneration ("wet" AMD) continues to be a leading cause of central vision loss in the US for those over fifty years of age, despite the availability of several effective interventions to contain damaging neovascularization (new, abnormal blood vessel growth). The effectiveness of treatments is challenged by patients' lack of ability to recognize the need for urgent care between regular office visits. The Amsler and Yanuzzi tests, the only widely used self-tests for AMD, have proven largely ineffective at enabling patients to recognize the signs that they should consult their retina specialist for treatment. For optimal benefit, patients should be able to self-monitor their vision over time and detect changes that may be indicative of an exudative event. To facilitate compliance these observations should be part of a larger and more engaging program of AMD awareness and self-monitoring. Among the principal shortcomings of the current "gold-standard" Amsler grid are periodicity of the test pattern and lack of individual adjustment, and therefore the reliability and accuracy of this test are less than optimal for the detection of exudative retinal changes in AMD patients. In phase I of the current study, the investigatorsW developed and evaluated several versions of improved grids, both on paper and on the Internet. These patent-pending Visual and Memory Stimulating (VMS) grids proved at least equivalent to the Amsler grid in facilitating a substantial degree of recall of prior measurements, necessary for monitoring vision over time. Adjustment features were incorporated in the on-line version to allow patients to customize their grid to their particular visual field. In the phase II study the use of VMS grids will be supplemented by a test booklet that contains educational materials and diary based survey questions in addition to the printed VMS grids; the effectiveness of this booklet for self-monitoring will be compared the standard o
Interventions
- BEHAVIORAL Standard of Care
- BEHAVIORAL VMS diary booklet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 324 participants |
| Start Date | 2010-05-01 |
| Est. Completion | 2015-03-26 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01337414
The ClinicalTrials.gov registry entry for NCT01337414 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 324 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.
NCT01337414 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01337414 about?
NCT01337414 is a clinical study titled "Tools to Optimize Patient Presentation After Onset of Exudative Age-Related Macular Degeneration (AMD)". Exudative age-related macular degeneration ("wet" AMD) continues to be a leading cause of central vision loss in the US for those over fifty years of age, despite the availability of several effective interventions to contain damaging neovascularization (new, abnormal blood vessel growth). The effec...
What is the current status of trial NCT01337414?
This trial is currently terminated. It is a NA study. The enrollment target is 324 participants. The study started on 2010-05-01. Estimated completion is 2015-03-26.
What interventions are being tested in trial NCT01337414?
The interventions under investigation include: Standard of Care (BEHAVIORAL), VMS diary booklet (BEHAVIORAL).
Who is sponsoring clinical trial NCT01337414?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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