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

Novartis Pharmaceuticals160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

160

Conditions

Age Related Macular Degeneration (AMD)

Interventions

Health Management Tool (HMT)OTHER

Mobile computing platform (ie HMT) which allows subjects to perform home monitoring tests

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (23)

Novartis Investigative Site

Beverly Hills, California, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

The disease diagnoses at baseline will be correlated to values of BCVA and CRST at baseline

Time frame: baseline

Correlation of monthly changes observed with thein the investigator judgment (CJ-C) to BCVA / OCT / Clinical examination

Data from ClinicalTrials.gov

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