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

Primary Purpose

Age Related Macular Degeneration (AMD)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health Management Tool (HMT)
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Age Related Macular Degeneration (AMD) focused on measuring ranibizumab, Age related Macular Degeneration, AMD, Health Management Tool, HMT, Best Corrected Visual Acuity, Investigator's Clinical Judgement of Change, Choroidal Neovascularization, Central Retinal Subfield Thickness, visual function self test

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Home Monitoring Test

Arm Description

Health management tool (HMT) for measuring vision impairment

Outcomes

Primary Outcome Measures

Threshold value of handheld Health Management Tool (HMT) for choroidal neovascular AMD diagnosis at baseline
Identification of clinically relevant worsening of visual function in the home self testing mVT scores

Secondary Outcome Measures

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
Correlation between the home deterioration signal and the monthly change in the handheld Health Management Tool (HMT) assessments performed during the site visits
Patient compliance and reliability of performing the home self testing using the handheld Health Management Tool (HMT)
Correlation between absolute values of the handheld Health Management Tool (HMT) and BCVA/ central retinal subfield thickness (CRST)
Correlation of the monthly changes in handheld Health Management Tool(HMT)to those of BCVA / OCT / Clinical examination
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
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.
Patient compliance with the signs and symptom questionnaire
The percentage of completed assessments of the signs & symptoms questionnaire on the HMT will be provided
Patient satisfaction regarding the use of the HMT

Full Information

First Posted
July 1, 2011
Last Updated
July 10, 2018
Sponsor
Novartis Pharmaceuticals
Collaborators
Carematix, VAS (Vital Art and Science)
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1. Study Identification

Unique Protocol Identification Number
NCT01542866
Brief Title
A 16 Week Evaluation of the Novartis Health Management Tool (HMT) in Age Related Macular Degeneration (AMD)
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
January 11, 2011 (Actual)
Primary Completion Date
November 30, 2011 (Actual)
Study Completion Date
November 30, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
Collaborators
Carematix, VAS (Vital Art and Science)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration (AMD)
Keywords
ranibizumab, Age related Macular Degeneration, AMD, Health Management Tool, HMT, Best Corrected Visual Acuity, Investigator's Clinical Judgement of Change, Choroidal Neovascularization, Central Retinal Subfield Thickness, visual function self test

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home Monitoring Test
Arm Type
Experimental
Arm Description
Health management tool (HMT) for measuring vision impairment
Intervention Type
Other
Intervention Name(s)
Health Management Tool (HMT)
Intervention Description
Mobile computing platform (ie HMT) which allows subjects to perform home monitoring tests
Primary Outcome Measure Information:
Title
Threshold value of handheld Health Management Tool (HMT) for choroidal neovascular AMD diagnosis at baseline
Time Frame
16 weeks
Title
Identification of clinically relevant worsening of visual function in the home self testing mVT scores
Time Frame
baseline to 16 weeks
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Patient compliance and reliability of performing the home self testing using the handheld Health Management Tool (HMT)
Time Frame
after 16 weeks
Title
Correlation between absolute values of the handheld Health Management Tool (HMT) and BCVA/ central retinal subfield thickness (CRST)
Time Frame
16 weeks
Title
Correlation of the monthly changes in handheld Health Management Tool(HMT)to those of BCVA / OCT / Clinical examination
Time Frame
after 16 weeks
Title
Correlation of diagnosis of choroidal neovascular AMD with BCVA/ central retinal subfield thickness
Description
The disease diagnoses at baseline will be correlated to values of BCVA and CRST at baseline
Time Frame
baseline
Title
Correlation of monthly changes observed with thein the investigator judgment (CJ-C) to BCVA / OCT / Clinical examination
Description
Monthly changes in BCVA /OCT and clinical examination will be compared to clinical relevant changes as judged by the investigator on the CJC.
Time Frame
baseline to 16 weeks
Title
Patient compliance with the signs and symptom questionnaire
Description
The percentage of completed assessments of the signs & symptoms questionnaire on the HMT will be provided
Time Frame
baseline to 16 weeks
Title
Patient satisfaction regarding the use of the HMT
Time Frame
16 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Novartis Investigative Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Novartis Investigative Site
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
Facility Name
Novartis Investigative Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Novartis Investigative Site
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Novartis Investigative Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Novartis Investigative Site
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
Facility Name
Novartis Investigative Site
City
Williamsburg
State/Province
Michigan
ZIP/Postal Code
49690
Country
United States
Facility Name
Novartis Investigative Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Novartis Investigative Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Novartis Investigative Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Novartis Investigative Site
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08753
Country
United States
Facility Name
Novartis Investigative Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Novartis Investigative Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Novartis Investigative Site
City
Slingerlands
State/Province
New York
ZIP/Postal Code
12159
Country
United States
Facility Name
Novartis Investigative Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Novartis Investigative Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Novartis Investigative Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Novartis Investigative Site
City
West Mifflin
State/Province
Pennsylvania
ZIP/Postal Code
15122
Country
United States
Facility Name
Novartis Investigative Site
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Novartis Investigative Site
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Novartis Investigative Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Novartis Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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