Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT01337414
Recruitment Status : Terminated (Lack of financial support)
First Posted : April 18, 2011
Last Update Posted : August 14, 2019
Sponsor:
Collaborators:
Results Group LLC
National Eye Institute (NEI)
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE April 15, 2011
First Posted Date  ICMJE April 18, 2011
Last Update Posted Date August 14, 2019
Actual Study Start Date  ICMJE May 1, 2010
Actual Primary Completion Date March 26, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tools to Optimize Patient Presentation After Onset of Exudative Age-Related Macular Degeneration (AMD)
Official Title  ICMJE Tools to Optimize Patient Presentation After Onset of Exudative AMD (Using the VMS Interactive Education and Early Detection Multi-Test)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Patient education and self-monitoring vs. customary care
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Age-related Macular Degeneration
Intervention  ICMJE
  • Behavioral: VMS diary booklet
  • Behavioral: Standard of Care
Study Arms  ICMJE
  • Experimental: VMS diary booklet
    Intervention: Behavioral: VMS diary booklet
  • Active Comparator: Usual Care (e.g. Amsler grid monitoring)
    Intervention: Behavioral: Standard of Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 12, 2019)
324
Original Estimated Enrollment  ICMJE
 (submitted: April 15, 2011)
1000
Actual Study Completion Date  ICMJE March 26, 2015
Actual Primary Completion Date March 26, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01337414
Other Study ID Numbers  ICMJE NA_00016895
2R44EY018990-02 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE
  • Results Group LLC
  • National Eye Institute (NEI)
Investigators  ICMJE Not Provided
PRS Account Johns Hopkins University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP