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

Sponsor

Johns Hopkins University (Other)

Overall Status

Terminated

CT.gov ID

NCT01337414

Collaborator

Results Group LLC (Industry), National Eye Institute (NEI) (NIH)

324

Enrollment

Location

Arms

58.8

Actual Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Age-related Macular Degeneration	Behavioral: VMS diary booklet Behavioral: Standard of Care	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

324 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patient education and self-monitoring vs. customary carePatient education and self-monitoring vs. customary care

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Tools to Optimize Patient Presentation After Onset of Exudative AMD (Using the VMS Interactive Education and Early Detection Multi-Test)

Actual Study Start Date :

May 1, 2010

Actual Primary Completion Date :

Mar 26, 2015

Actual Study Completion Date :

Mar 26, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VMS diary booklet	Behavioral: VMS diary booklet
Active Comparator: Usual Care (e.g. Amsler grid monitoring)	Behavioral: Standard of Care

Arm

Intervention/Treatment

Experimental: VMS diary booklet

Behavioral: VMS diary booklet

Active Comparator: Usual Care (e.g. Amsler grid monitoring)

Behavioral: Standard of Care

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects with a confirmed diagnosis of AREDS grade 3 or 4 AMD in at least one eye will be recruited for components 1 and 2 of the study. The participants will include healthy adults who are willing and able to complete the study tests. We will recruit AMD patients across a wide range of races and ages, but due to the prevalence of AMD, most of the patients will be Caucasian and over age 55. We will verify ocular diagnosis and visual function status of all subjects through records and communication provided by their retinal specialist.

Exclusion Criteria:

Subjects with vision loss due to ocular pathology other than AMD or cataracts will be excluded.
Subjects with cataract extraction in the last 3 months or capsulotomy in the last 24 hours in either eye will also be excluded, as well as those who are unable to give informed consent, non-English speaking or unable complete any other required study procedure.