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: July 25, 2013
Last verified: July 2013

July 1, 2011
July 25, 2013
June 2011
December 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01542866 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A 16 Week Evaluation of the Novartis Health Management Tool (HMT) in Age Related Macular Degeneration (AMD)
A 16 Week Evaluation of the Novartis Health Management Tool in Assessing Self-test Visual Function in Patients With AMD Treated With Ranibizumab

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.

Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Age Related Macular Degeneration (AMD)
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
other application for monitoring
Intervention: Device: Health Management Tool (HMT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01542866
CRFB002A2407
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Carematix, VAS (Vital Art and Science)
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP