Age Related Macular Degeneration (AMD)
Conditions
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
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.
Interventions
OTHERHealth Management Tool (HMT)
Mobile computing platform (ie HMT) which allows subjects to perform home monitoring tests
Sponsors
Carematix, VAS (Vital Art and Science)
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 |
| Patient satisfaction regarding the use of the HMT | 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 |
| Correlation of the monthly changes in handheld Health Management Tool(HMT)to those of BCVA / OCT / Clinical examination | after 16 weeks | — |
Countries
United States
Outcome results
None listed