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Completed

NCT Number: NCT01542866

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

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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Key information

Conditions

Age Related Macular Degeneration (AMD) Choroid Diseases Choroidal Neovascularization Eye Diseases Macular Degeneration Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Uveal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Novartis Investigative Site, Beverly Hills, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health Management Tool (HMT)

Other

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

Primary outcomes

  1. Threshold value of handheld Health Management Tool (HMT) for choroidal neovascular AMD diagnosis at baseline

    Time frame: 16 weeks

  2. Identification of clinically relevant worsening of visual function in the home self testing mVT scores

    Time frame: baseline to 16 weeks

Secondary outcomes

  1. 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

  2. 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

  3. Patient compliance and reliability of performing the home self testing using the handheld Health Management Tool (HMT)

    Time frame: after 16 weeks

  4. Correlation between absolute values of the handheld Health Management Tool (HMT) and BCVA/ central retinal subfield thickness (CRST)

    Time frame: 16 weeks

  5. Correlation of the monthly changes in handheld Health Management Tool(HMT)to those of BCVA / OCT / Clinical examination

    Time frame: after 16 weeks

  6. Correlation of diagnosis of choroidal neovascular AMD with BCVA/ central retinal subfield thickness

    Time frame: baseline

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

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

    Time frame: 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.

  8. Patient compliance with the signs and symptom questionnaire

    Time frame: baseline to 16 weeks

    The percentage of completed assessments of the signs & symptoms questionnaire on the HMT will be provided

  9. Patient satisfaction regarding the use of the HMT

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Collaborators

  • Carematix, VAS (Vital Art and Science)

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 2, 2012
Registry last updated
Jul 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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