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| Name | Class |
|---|---|
| Carematix, VAS (Vital Art and Science) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home Monitoring Test | Experimental | Health management tool (HMT) for measuring vision impairment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Management Tool (HMT) | Other | Mobile computing platform (ie HMT) which allows subjects to perform home monitoring tests |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Beverly Hills | California | 90211 | United States | ||
| Novartis Investigative Site |
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| 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 |
| Sacramento |
| California |
| 95819 |
| United States |
| Novartis Investigative Site | Torrance | California | 90503 | United States |
| Novartis Investigative Site | Fort Myers | Florida | 33901 | United States |
| Novartis Investigative Site | Largo | Florida | 33770 | United States |
| Novartis Investigative Site | Sarasota | Florida | 34239 | United States |
| Novartis Investigative Site | Springfield | Illinois | 62704 | United States |
| Novartis Investigative Site | Williamsburg | Michigan | 49690 | United States |
| Novartis Investigative Site | Lincoln | Nebraska | 68506 | United States |
| Novartis Investigative Site | Omaha | Nebraska | 68131 | United States |
| Novartis Investigative Site | Las Vegas | Nevada | 89144 | United States |
| Novartis Investigative Site | Toms River | New Jersey | 08753 | United States |
| Novartis Investigative Site | New York | New York | 10021 | United States |
| Novartis Investigative Site | Rochester | New York | 14620 | United States |
| Novartis Investigative Site | Slingerlands | New York | 12159 | United States |
| Novartis Investigative Site | Charlotte | North Carolina | 28210 | United States |
| Novartis Investigative Site | Cincinnati | Ohio | 45242 | United States |
| Novartis Investigative Site | Cleveland | Ohio | 44195 | United States |
| Novartis Investigative Site | West Mifflin | Pennsylvania | 15122 | United States |
| Novartis Investigative Site | Rapid City | South Dakota | 57701 | United States |
| Novartis Investigative Site | Kingsport | Tennessee | 37660 | United States |
| Novartis Investigative Site | Nashville | Tennessee | 37203 | United States |
| Novartis Investigative Site | San Antonio | Texas | 78240 | United States |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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