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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01542866

First Posted: March 2, 2012

Last Update Posted: November 18, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Carematix, VAS (Vital Art and Science)

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

Tracking Information

First Submitted Date ^ICMJE

July 1, 2011

First Posted Date ^ICMJE

March 2, 2012

Last Update Posted Date

November 18, 2016

Start Date ^ICMJE

June 2011

Primary Completion Date

December 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

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

Enrollment ^ICMJE

160

Completion Date

December 2011

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

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

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

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

To Top