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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
The Results Group
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01337414
First received: April 15, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
  Purpose

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 Intervention Phase
Age-related Macular Degeneration
Behavioral: VMS diary booklet
Behavioral: Standard of Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Estimated Enrollment: 1000
Study Start Date: May 2010
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VMS diary booklet Behavioral: VMS diary booklet
Active Comparator: Usual Care (e.g. Amsler grid monitoring) Behavioral: Standard of Care

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01337414

Contacts
Contact: Gislin Dagnelie, PhD 410-614-4822 gdagnelie@jhmi.edu
Contact: Ava K Bittner, OD, PhD 410-502-6430 abittne1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins University Wilmer Eye Institute Recruiting
Baltimore, Maryland, United States, 21205
Contact: Ellen Arnold    410-955-6782    earnol16@jhmi.edu   
Contact: Gislin Dagnelie, PhD    410-614-4822    gdagnelie@jhmi.edu   
Principal Investigator: Gislin Dagnelie, PhD         
Sub-Investigator: Ava K Bittner, OD, PhD         
Sponsors and Collaborators
Johns Hopkins University
The Results Group
  More Information

No publications provided

Responsible Party: Gislin Dagnelie, PhD; and Mark Roser, Johns Hopkins University; and The Results Group
ClinicalTrials.gov Identifier: NCT01337414     History of Changes
Other Study ID Numbers: 2R44EY018990-02
Study First Received: April 15, 2011
Last Updated: April 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
age-related macular degeneration
screening
monitoring
diagnosis
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
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 28, 2014