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
: November 18, 2016
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Sponsor:
Novartis Pharmaceuticals
Collaborator:
Carematix, VAS (Vital Art and Science)
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
Tracking Information | ||||
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First Submitted Date ICMJE | July 1, 2011 | |||
First Posted Date ICMJE | March 2, 2012 | |||
Last Update Posted Date | November 18, 2016 | |||
Study Start Date ICMJE | June 2011 | |||
Actual Primary Completion Date | December 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01542866 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A 16 Week Evaluation of the Novartis Health Management Tool (HMT) in Age Related Macular Degeneration (AMD) | |||
Official Title ICMJE | A 16 Week Evaluation of the Novartis Health Management Tool in Assessing Self-test Visual Function in Patients With AMD Treated With Ranibizumab | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) |
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Condition ICMJE | Age Related Macular Degeneration (AMD) | |||
Intervention ICMJE | 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 |
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Study Arms | other application for monitoring
Intervention: Device: Health Management Tool (HMT) |
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Publications * | Kaiser PK, Wang YZ, He YG, Weisberger A, Wolf S, Smith CH. Feasibility of a novel remote daily monitoring system for age-related macular degeneration using mobile handheld devices: results of a pilot study. Retina. 2013 Oct;33(9):1863-70. doi: 10.1097/IAE.0b013e3182899258. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
160 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | December 2011 | |||
Actual Primary Completion Date | December 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | 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 | NCT01542866 | |||
Other Study ID Numbers ICMJE | CRFB002A2407 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Novartis ( Novartis Pharmaceuticals ) | |||
Study Sponsor ICMJE | Novartis Pharmaceuticals | |||
Collaborators ICMJE | Carematix, VAS (Vital Art and Science) | |||
Investigators ICMJE |
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PRS Account | Novartis | |||
Verification Date | November 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |