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

Study Overview
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Brief Summary
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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.

Official Title
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A 16 Week Evaluation of the Novartis Health Management Tool in Assessing Self-test Visual Function in Patients With AMD Treated With Ranibizumab

Conditions
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Age Related Macular Degeneration (AMD)

Intervention / Treatment
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* Other: Health Management Tool (HMT)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home Monitoring Test<br>Health management tool (HMT) for measuring vision impairment | Other: Health Management Tool (HMT)<br>* Mobile computing platform (ie HMT) which allows subjects to perform home monitoring tests<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 
| Patient compliance and reliability of performing the home self testing using the handheld Health Management Tool (HMT) |  | 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 the monthly changes in handheld Health Management Tool(HMT)to those of BCVA / OCT / Clinical examination |  | 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 | 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. | baseline to 16 weeks | 
| 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 | 
| Patient satisfaction regarding the use of the HMT |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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