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

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ClinicalTrials.gov Identifier: NCT01542866
Recruitment Status : Completed
First Posted : March 2, 2012
Last Update Posted : July 12, 2018
Sponsor:
Collaborator:
Carematix, VAS (Vital Art and Science)
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Age Related Macular Degeneration (AMD) Other: Health Management Tool (HMT) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : January 11, 2011
Actual Primary Completion Date : November 30, 2011
Actual Study Completion Date : November 30, 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Home Monitoring Test
Health management tool (HMT) for measuring vision impairment
Other: Health Management Tool (HMT)
Mobile computing platform (ie HMT) which allows subjects to perform home monitoring tests




Primary Outcome Measures :
  1. Threshold value of handheld Health Management Tool (HMT) for choroidal neovascular AMD diagnosis at baseline [ Time Frame: 16 weeks ]
  2. Identification of clinically relevant worsening of visual function in the home self testing mVT scores [ Time Frame: baseline to 16 weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Patient compliance and reliability of performing the home self testing using the handheld Health Management Tool (HMT) [ Time Frame: after 16 weeks ]
  4. Correlation between absolute values of the handheld Health Management Tool (HMT) and BCVA/ central retinal subfield thickness (CRST) [ Time Frame: 16 weeks ]
  5. Correlation of the monthly changes in handheld Health Management Tool(HMT)to those of BCVA / OCT / Clinical examination [ Time Frame: after 16 weeks ]
  6. Correlation of diagnosis of choroidal neovascular AMD with BCVA/ central retinal subfield thickness [ Time Frame: baseline ]
    The disease diagnoses at baseline will be correlated to values of BCVA and CRST at baseline

  7. Correlation of monthly changes observed with thein the investigator judgment (CJ-C) to BCVA / OCT / Clinical examination [ Time Frame: baseline to 16 weeks ]
    Monthly changes in BCVA /OCT and clinical examination will be compared to clinical relevant changes as judged by the investigator on the CJC.

  8. Patient compliance with the signs and symptom questionnaire [ Time Frame: baseline to 16 weeks ]
    The percentage of completed assessments of the signs & symptoms questionnaire on the HMT will be provided

  9. Patient satisfaction regarding the use of the HMT [ Time Frame: 16 weeks ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT01542866


  Show 23 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Carematix, VAS (Vital Art and Science)
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01542866     History of Changes
Other Study ID Numbers: CRFB002A2407
First Posted: March 2, 2012    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents