NCT01337414

Tools to Optimize Patient Presentation After Onset of Exudative Age-Related Macular Degeneration (AMD)

Terminated NA Last updated 14 August 2019

What this trial tests

NA trial testing VMS diary booklet in Age-related Macular Degeneration in 324 participants. Terminated before completion.

Timeline

1 May 2010

Primary endpoint
26 March 2015

26 March 2015

Quick facts

Lead sponsor	Johns Hopkins University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	324
Start date	1 May 2010
Primary completion	26 March 2015
Estimated completion	26 March 2015
Sites	1 location across United States

Drugs / interventions tested

• VMS diary booklet
• Standard of Care

Conditions studied

• Age-related Macular Degeneration — all drugs for Age-related Macular Degeneration →

Sponsor

Johns Hopkins University

Who can join

Eligibility, any sex, with Age-related Macular Degeneration. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 of care (Amsler grid).

Goal of the study is to demonstrate that use of the test booklet leads to more rapid identification of newly developing vision problems, earlier diagnosis and treatment of incipient wet AMD that should result in fewer people losing their vision and less severe losses of vision.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Improved Adherence to Vision Self-monitoring with the Vision and Memory Stimulating (VMS) Journal for Non-neovascular Age-related Macular Degeneration during a Randomized Controlled Trial.
   Bittner AK, Torr-Brown S, Arnold E, Nwankwo A, et al · · 2014 · cited 7× · PMID 24791222 · DOI 10.4172/2155-9570.1000320