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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01337414
Recruitment Status : Unknown
Verified April 2011 by Johns Hopkins University.
Recruitment status was:  Recruiting
First Posted : April 18, 2011
Last Update Posted : April 18, 2011
The Results Group
National Eye Institute (NEI)
Information provided by:
Johns Hopkins University

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 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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)
Study Start Date : May 2010
Estimated Primary Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01337414

Contact: Gislin Dagnelie, PhD 410-614-4822
Contact: Ava K Bittner, OD, PhD 410-502-6430

United States, Maryland
Johns Hopkins University Wilmer Eye Institute Recruiting
Baltimore, Maryland, United States, 21205
Contact: Ellen Arnold    410-955-6782   
Contact: Gislin Dagnelie, PhD    410-614-4822   
Principal Investigator: Gislin Dagnelie, PhD         
Sub-Investigator: Ava K Bittner, OD, PhD         
Sponsors and Collaborators
Johns Hopkins University
The Results Group
National Eye Institute (NEI)

Responsible Party: Gislin Dagnelie, PhD; and Mark Roser, Johns Hopkins University; and The Results Group Identifier: NCT01337414     History of Changes
Other Study ID Numbers: 2R44EY018990-02 ( U.S. NIH Grant/Contract )
First Posted: April 18, 2011    Key Record Dates
Last Update Posted: April 18, 2011
Last Verified: April 2011

Keywords provided by Johns Hopkins University:
age-related macular degeneration
dry or non-neovascular age-related macular degeneration (high risk, intermediate, geographic atrophy or AREDS grade 3/4 AMD)

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases