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

Tracking Information
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; (submitted: March 1, 2012)	Threshold value of handheld Health Management Tool (HMT) for choroidal neovascular AMD diagnosis at baseline [ Time Frame: 16 weeks ]; Identification of clinically relevant worsening of visual function in the home self testing mVT scores [ Time Frame: baseline to 16 weeks ]
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; (submitted: March 1, 2012)	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 ]; 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 ]; Patient compliance and reliability of performing the home self testing using the handheld Health Management Tool (HMT) [ Time Frame: after 16 weeks ]; Correlation between absolute values of the handheld Health Management Tool (HMT) and BCVA/ central retinal subfield thickness (CRST) [ Time Frame: 16 weeks ]; Correlation of the monthly changes in handheld Health Management Tool(HMT)to those of BCVA / OCT / Clinical examination [ Time Frame: after 16 weeks ]; 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; Correlation of monthly changes observed within 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.; 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; Patient satisfaction regarding the use of the HMT [ Time Frame: 16 weeks ]
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)
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
Study Arms	other application for monitoring; Intervention: Device: Health Management Tool (HMT)
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.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: March 1, 2012)	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: 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
Sex/Gender	Sexes Eligible for Study: All
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	Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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