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

Not Applicable

Completed

• Conditions: Age Related Macular Degeneration (AMD)
• Interventions: Other: Health Management Tool (HMT)

• Registration Number: NCT01542866
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-11
• Study First Submitted: 2011-07-01
• Primary Completion: 2011-11-30
• Study Completion: 2011-11-30
• Study First Submitted QC: 2012-03-01
• Study First Posted: 2012-03-02
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-10
• Last Update Posted: 2018-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Home Monitoring Test	Health Management Tool (HMT)	Health management tool (HMT) for measuring vision impairment

Primary Outcome Measures

Name	Time	Method
Identification of clinically relevant worsening of visual function in the home self testing mVT scores	baseline to 16 weeks
Threshold value of handheld Health Management Tool (HMT) for choroidal neovascular AMD diagnosis at baseline	16 weeks

Secondary Outcome Measures

Name	Time	Method
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
Correlation between absolute values of the handheld Health Management Tool (HMT) and BCVA/ central retinal subfield thickness (CRST)	16 weeks
Correlation of diagnosis of choroidal neovascular AMD with BCVA/ central retinal subfield thickness	baseline	The disease diagnoses at baseline will be correlated to values of BCVA and CRST at baseline
Patient satisfaction regarding the use of the HMT	16 weeks
Patient compliance and reliability of performing the home self testing using the handheld Health Management Tool (HMT)	after 16 weeks
Patient compliance with the signs and symptom questionnaire	baseline to 16 weeks	The percentage of completed assessments of the signs \& symptoms questionnaire on the HMT will be provided
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
Correlation of the monthly changes in handheld Health Management Tool(HMT)to those of BCVA / OCT / Clinical examination	after 16 weeks
Correlation of monthly changes observed with thein the investigator judgment (CJ-C) to BCVA / OCT / Clinical examination	baseline to 16 weeks	Monthly changes in BCVA /OCT and clinical examination will be compared to clinical relevant changes as judged by the investigator on the CJC.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇸 San Antonio, Texas, United States