A 16 Week Evaluation of the Novartis Health Management Tool (HMT) in Age Related Macular Degeneration (AMD)
1 other identifier
interventional
160
1 country
23
Brief Summary
This is a prospective pilot study to evaluate the usability and applicability of a self monitoring test of visual function with the handheld Health Management Tool (HMT) to remotely monitor neovascular Age Related Macular Degeneration (AMD) to detect a potential change in disease status.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2011
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 11, 2011
CompletedFirst Submitted
Initial submission to the registry
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2011
CompletedFirst Posted
Study publicly available on registry
March 2, 2012
CompletedJuly 12, 2018
July 1, 2018
11 months
July 1, 2011
July 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Threshold value of handheld Health Management Tool (HMT) for choroidal neovascular AMD diagnosis at baseline
16 weeks
Identification of clinically relevant worsening of visual function in the home self testing mVT scores
baseline to 16 weeks
Secondary Outcomes (9)
Correlation of the handheld Health Management Tool (HMT) home self testing on the days of site visits and the mVT assessments performed during the site visits for absolute values
after 16 weeks
Correlation between the home deterioration signal and the monthly change in the handheld Health Management Tool (HMT) assessments performed during the site visits
after 16 weeks
Patient compliance and reliability of performing the home self testing using the handheld Health Management Tool (HMT)
after 16 weeks
Correlation between absolute values of the handheld Health Management Tool (HMT) and BCVA/ central retinal subfield thickness (CRST)
16 weeks
Correlation of the monthly changes in handheld Health Management Tool(HMT)to those of BCVA / OCT / Clinical examination
after 16 weeks
- +4 more secondary outcomes
Study Arms (1)
Home Monitoring Test
EXPERIMENTALHealth management tool (HMT) for measuring vision impairment
Interventions
Mobile computing platform (ie HMT) which allows subjects to perform home monitoring tests
Eligibility Criteria
You may qualify if:
- Patients with CNV secondary to AMD and not other causes in at least one eye identified by the investigator to be eligible for ranibizumab treatment
- Patients with a BCVA letter score in the study eye is 24 or better using an ETDRS chart measured at 4 meters distance
You may not qualify if:
- Patients with any concurrent ocular condition that may result in visual loss during the study
- Patients with past (within the prior 6 months) or current use of, or likely need for, systemic medications that are known to be toxic to the lens, retina, or optic nerve
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartis Pharmaceuticalslead
- Carematix, VAS (Vital Art and Science)collaborator
Study Sites (23)
Novartis Investigative Site
Beverly Hills, California, 90211, United States
Novartis Investigative Site
Sacramento, California, 95819, United States
Novartis Investigative Site
Torrance, California, 90503, United States
Novartis Investigative Site
Fort Myers, Florida, 33901, United States
Novartis Investigative Site
Largo, Florida, 33770, United States
Novartis Investigative Site
Sarasota, Florida, 34239, United States
Novartis Investigative Site
Springfield, Illinois, 62704, United States
Novartis Investigative Site
Williamsburg, Michigan, 49690, United States
Novartis Investigative Site
Lincoln, Nebraska, 68506, United States
Novartis Investigative Site
Omaha, Nebraska, 68131, United States
Novartis Investigative Site
Las Vegas, Nevada, 89144, United States
Novartis Investigative Site
Toms River, New Jersey, 08753, United States
Novartis Investigative Site
New York, New York, 10021, United States
Novartis Investigative Site
Rochester, New York, 14620, United States
Novartis Investigative Site
Slingerlands, New York, 12159, United States
Novartis Investigative Site
Charlotte, North Carolina, 28210, United States
Novartis Investigative Site
Cincinnati, Ohio, 45242, United States
Novartis Investigative Site
Cleveland, Ohio, 44195, United States
Novartis Investigative Site
West Mifflin, Pennsylvania, 15122, United States
Novartis Investigative Site
Rapid City, South Dakota, 57701, United States
Novartis Investigative Site
Kingsport, Tennessee, 37660, United States
Novartis Investigative Site
Nashville, Tennessee, 37203, United States
Novartis Investigative Site
San Antonio, Texas, 78240, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2011
First Posted
March 2, 2012
Study Start
January 11, 2011
Primary Completion
November 30, 2011
Study Completion
November 30, 2011
Last Updated
July 12, 2018
Record last verified: 2018-07