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

Age Related Macular Degeneration (AMD) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01542866
• Other study ID #: CRFB002A2407
• Status: Completed
• Phase: N/A
• Start date: January 11, 2011
• Est. completion date: November 30, 2011

Study information

• Verified date: July 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: November 30, 2011
• Est. primary completion date: November 30, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Age Related Macular Degeneration (AMD)
• Macular Degeneration

Intervention

Other:
• Health Management Tool (HMT)
Mobile computing platform (ie HMT) which allows subjects to perform home monitoring tests

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Beverly Hills	California
United States	Novartis Investigative Site	Charlotte	North Carolina
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investigative Site	Cleveland	Ohio
United States	Novartis Investigative Site	Fort Myers	Florida
United States	Novartis Investigative Site	Kingsport	Tennessee
United States	Novartis Investigative Site	Largo	Florida
United States	Novartis Investigative Site	Las Vegas	Nevada
United States	Novartis Investigative Site	Lincoln	Nebraska
United States	Novartis Investigative Site	Nashville	Tennessee
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	Omaha	Nebraska
United States	Novartis Investigative Site	Rapid City	South Dakota
United States	Novartis Investigative Site	Rochester	New York
United States	Novartis Investigative Site	Sacramento	California
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	Sarasota	Florida
United States	Novartis Investigative Site	Slingerlands	New York
United States	Novartis Investigative Site	Springfield	Illinois
United States	Novartis Investigative Site	Toms River	New Jersey
United States	Novartis Investigative Site	Torrance	California
United States	Novartis Investigative Site	West Mifflin	Pennsylvania
United States	Novartis Investigative Site	Williamsburg	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals	Carematix, VAS (Vital Art and Science)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Threshold value of handheld Health Management Tool (HMT) for choroidal neovascular AMD diagnosis at baseline		16 weeks
Primary	Identification of clinically relevant worsening of visual function in the home self testing mVT scores		baseline to 16 weeks
Secondary	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		after 16 weeks
Secondary	Correlation between the home deterioration signal and the monthly change in the handheld Health Management Tool (HMT) assessments performed during the site visits		after 16 weeks
Secondary	Patient compliance and reliability of performing the home self testing using the handheld Health Management Tool (HMT)		after 16 weeks
Secondary	Correlation between absolute values of the handheld Health Management Tool (HMT) and BCVA/ central retinal subfield thickness (CRST)		16 weeks
Secondary	Correlation of the monthly changes in handheld Health Management Tool(HMT)to those of BCVA / OCT / Clinical examination		after 16 weeks
Secondary	Correlation of diagnosis of choroidal neovascular AMD with BCVA/ central retinal subfield thickness	The disease diagnoses at baseline will be correlated to values of BCVA and CRST at baseline	baseline
Secondary	Correlation of monthly changes observed with thein the investigator judgment (CJ-C) to BCVA / OCT / Clinical examination	Monthly changes in BCVA /OCT and clinical examination will be compared to clinical relevant changes as judged by the investigator on the CJC.	baseline to 16 weeks
Secondary	Patient compliance with the signs and symptom questionnaire	The percentage of completed assessments of the signs & symptoms questionnaire on the HMT will be provided	baseline to 16 weeks
Secondary	Patient satisfaction regarding the use of the HMT		16 weeks