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A 16 Week Evaluation of the Novartis Health Management Tool (HMT) in Age Related Macular Degeneration (AMD)

This study has been completed.
Sponsor:
Collaborator:
Carematix, VAS (Vital Art and Science)
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01542866
First received: July 1, 2011
Last updated: March 1, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Age Related Macular Degeneration (AMD)
 Device: Health Management Tool (HMT)
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A 16 Week Evaluation of the Novartis Health Management Tool in Assessing Self-test Visual Function in Patients With AMD Treated With Ranibizumab

Resource links provided by NLM:

Drug Information available for: Ranibizumab
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Threshold value of handheld Health Management Tool (HMT) for choroidal neovascular AMD diagnosis at baseline [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Identification of clinically relevant worsening of visual function in the home self testing mVT scores [ Time Frame: baseline to 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: after 16 weeks ] [ Designated as safety issue: No ]
  • Correlation between the home deterioration signal and the monthly change in the handheld Health Management Tool (HMT) assessments performed during the site visits [ Time Frame: after 16 weeks ] [ Designated as safety issue: No ]
  • Patient compliance and reliability of performing the home self testing using the handheld Health Management Tool (HMT) [ Time Frame: after 16 weeks ] [ Designated as safety issue: No ]
  • Correlation between absolute values of the handheld Health Management Tool (HMT) and BCVA/ central retinal subfield thickness (CRST) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Correlation of the monthly changes in handheld Health Management Tool(HMT)to those of BCVA / OCT / Clinical examination [ Time Frame: after 16 weeks ] [ Designated as safety issue: No ]
  • Correlation of diagnosis of choroidal neovascular AMD with BCVA/ central retinal subfield thickness [ Time Frame: baseline ] [ Designated as safety issue: No ]
    The disease diagnoses at baseline will be correlated to values of BCVA and CRST at baseline

  • Correlation of monthly changes observed within the investigator judgment (CJ-C) to BCVA / OCT / Clinical examination [ Time Frame: baseline to 16 weeks ] [ Designated as safety issue: No ]
    Monthly changes in BCVA /OCT and clinical examination will be compared to clinical relevant changes as judged by the investigator on the CJC.

  • Patient compliance with the signs and symptom questionnaire [ Time Frame: baseline to 16 weeks ] [ Designated as safety issue: No ]
    The percentage of completed assessments of the signs & symptoms questionnaire on the HMT will be provided

  • Patient satisfaction regarding the use of the HMT [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: June 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
other application for monitoring Device: Health Management Tool (HMT)
utilization of software specific for measuring vision impairment on a mobile computing platform (ie HMT) which allows subjects to perform home monitoring tests

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Other protocol-defined inclusion/exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542866

Locations
United States, California
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
Retinal Consultants Medical Group of Sacramento
Sacramento, California, United States, 95819
Retina Macula Institute
Torrance, California, United States, 90503
United States, Florida
Retina Health Center
Fort Meyers, Florida, United States, 33907
The Eye Institute of West Florida
Largo, Florida, United States, 28210
Sarasota Retina Institute Research Foundation
Sarasota, Florida, United States, 34239
United States, Michigan
Vision Research Foundation
Traverse City, Michigan, United States, 49686
United States, Nebraska
Eye Surgical Associates
Lincoln, Nebraska, United States, 68506
Midwest Eye Care
Omaha, Nebraska, United States, 68131
United States, Nevada
Retina Consultants of Nevada
Las Vegas, Nevada, United States, 89144
United States, New Jersey
Retina-Vitreous Center
Tom's River, New Jersey, United States, 08755
United States, New York
Macula Care
New York, New York, United States, 10021
Retina Associates of Western New York
Rochester, New York, United States, 14620
United States, North Carolina
Charlotte Eye, Ear, Nose and Throat Associates
Belmont, North Carolina, United States, 28012
United States, Ohio
Cincinnati Eye Institute
Cincinnati, Ohio, United States, 45242
Cleveland Clinic Cole/Eye Institute
Cleveland, Ohio, United States, 44915
United States, Pennsylvania
Associates in Opthamology
West Mifflin, Pennsylvania, United States, 14620
United States, South Dakota
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Southeastern Retina Associates
Kingsport, Tennessee, United States, 37660
TN Retina
Nashville, Tennessee, United States, 37203
United States, Texas
Retinal Consultants of San Antonio
San Antonio, Texas, United States, 78240
Sponsors and Collaborators
Novartis Pharmaceuticals
Carematix, VAS (Vital Art and Science)
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01542866     History of Changes
Other Study ID Numbers: CRFB002A2407
Study First Received: July 1, 2011
Last Updated: March 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Novartis:
ranibizumab
Age related Macular Degeneration
AMD
Health Management Tool
HMT
 Best Corrected Visual Acuity
Investigator's Clinical Judgement of Change
Choroidal Neovascularization
Central Retinal Subfield Thickness
visual function self test

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

ClinicalTrials.gov processed this record on May 19, 2013