Clinical trial NCT01542866: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Carematix, VAS (Vital Art and Science)
First posted: 2012-03-02
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Threshold value of handheld Health Management Tool (HMT) for choroidal neovascular AMD diagnosis at baseline
timeFrame: 16 weeks
measure: Identification of clinically relevant worsening of visual function in the home self testing mVT scores
timeFrame: baseline to 16 weeks
Secondary outcomes:
measure: 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
timeFrame: after 16 weeks
measure: Correlation between the home deterioration signal and the monthly change in the handheld Health Management Tool (HMT) assessments performed during the site visits
timeFrame: after 16 weeks
measure: Patient compliance and reliability of performing the home self testing using the handheld Health Management Tool (HMT)
timeFrame: after 16 weeks
measure: Correlation between absolute values of the handheld Health Management Tool (HMT) and BCVA/ central retinal subfield thickness (CRST)
timeFrame: 16 weeks
measure: Correlation of the monthly changes in handheld Health Management Tool(HMT)to those of BCVA / OCT / Clinical examination
timeFrame: after 16 weeks
measure: Correlation of diagnosis of choroidal neovascular AMD with BCVA/ central retinal subfield thickness
timeFrame: baseline
measure: Correlation of monthly changes observed with thein the investigator judgment (CJ-C) to BCVA / OCT / Clinical examination
timeFrame: baseline to 16 weeks
measure: Patient compliance with the signs and symptom questionnaire
timeFrame: baseline to 16 weeks
measure: Patient satisfaction regarding the use of the HMT
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Novartis Investigative Site
state: California
city: Sacramento
country: United States
facility: Novartis Investigative Site
state: California
city: Torrance
country: United States
facility: Novartis Investigative Site
state: California
city: Fort Myers
country: United States
facility: Novartis Investigative Site
state: Florida
city: Largo
country: United States
facility: Novartis Investigative Site
state: Florida
city: Sarasota
country: United States
facility: Novartis Investigative Site
state: Florida
city: Springfield
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Williamsburg
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Lincoln
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Omaha
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Las Vegas
country: United States
facility: Novartis Investigative Site
state: Nevada
city: Toms River
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: Rochester
country: United States
facility: Novartis Investigative Site
state: New York
city: Slingerlands
country: United States
facility: Novartis Investigative Site
state: New York
city: Charlotte
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Cincinnati
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Cleveland
country: United States
facility: Novartis Investigative Site
state: Ohio
city: West Mifflin
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Rapid City
country: United States
facility: Novartis Investigative Site
state: South Dakota
city: Kingsport
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Nashville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: San Antonio
country: United States
facility: Novartis Investigative Site
state: Texas
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: