Age Related Macular Degeneration (AMD)NCT01542866
A 16 Week Evaluation of the Novartis Health Management Tool (HMT) in Age Related Macular Degeneration (AMD)
A study testing Health Management Tool (HMT) in people with Age Related Macular Degeneration (AMD), run by Novartis Pharmaceuticals at 23 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Age Related Macular Degeneration (AMD)
- What is being tested?
- Health Management Tool (HMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 23 sitesUnited States
- Study dates
- 11 Jan 2011to 30 Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Novartis Investigative Site
Beverly Hills, California, 90211
Novartis Investigative Site
Charlotte, North Carolina, 28210
Novartis Investigative Site
Cincinnati, Ohio, 45242
Novartis Investigative Site
Cleveland, Ohio, 44195
Novartis Investigative Site
Fort Myers, Florida, 33901
Novartis Investigative Site
Kingsport, Tennessee, 37660
Novartis Investigative Site
Largo, Florida, 33770
Novartis Investigative Site
Las Vegas, Nevada, 89144
Novartis Investigative Site
Lincoln, Nebraska, 68506
Novartis Investigative Site
Nashville, Tennessee, 37203
Novartis Investigative Site
New York, New York, 10021
Novartis Investigative Site
Omaha, Nebraska, 68131
Novartis Investigative Site
Rapid City, South Dakota, 57701
Novartis Investigative Site
Rochester, New York, 14620
Novartis Investigative Site
Sacramento, California, 95819
Novartis Investigative Site
San Antonio, Texas, 78240
Novartis Investigative Site
Sarasota, Florida, 34239
Novartis Investigative Site
Slingerlands, New York, 12159
Novartis Investigative Site
Springfield, Illinois, 62704
Novartis Investigative Site
Toms River, New Jersey, 08753
Novartis Investigative Site
Torrance, California, 90503
Novartis Investigative Site
West Mifflin, Pennsylvania, 15122
Novartis Investigative Site
Williamsburg, Michigan, 49690
About this study
Official title: A 16 Week Evaluation of the Novartis Health Management Tool in Assessing Self-test Visual Function in Patients With AMD Treated With Ranibizumab
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.
- Conditions
- Age Related Macular Degeneration (AMD)
- Being tested
- Health Management Tool (HMT)
- 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
- Medical subject headings
- Macular Degeneration, Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Management Tool (HMT)Other
Mobile computing platform (ie HMT) which allows subjects to perform home monitoring tests
| Study group | Role | What they receive |
|---|---|---|
| Home Monitoring Test | Experimental | Health management tool (HMT) for measuring vision impairment Receives: Other: Health Management Tool (HMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Threshold value of handheld Health Management Tool (HMT) for choroidal neovascular AMD diagnosis at baseline
Measured: 16 weeks
Identification of clinically relevant worsening of visual function in the home self testing mVT scores
Measured: baseline to 16 weeks
Secondary outcomes (9)
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
Measured: 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
Measured: after 16 weeks
Patient compliance and reliability of performing the home self testing using the handheld Health Management Tool (HMT)
Measured: after 16 weeks
Correlation between absolute values of the handheld Health Management Tool (HMT) and BCVA/ central retinal subfield thickness (CRST)
Measured: 16 weeks
Correlation of the monthly changes in handheld Health Management Tool(HMT)to those of BCVA / OCT / Clinical examination
Measured: 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
Measured: 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.
Measured: 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
Measured: baseline to 16 weeks
Patient satisfaction regarding the use of the HMT
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study start11 Jan 2011
- Primary completion30 Nov 2011
- Study completion30 Nov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular Degeneration (AMD)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Carematix, VAS (Vital Art and Science)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542866
- Sponsor's protocol ID
- CRFB002A2407
- Status last verified
- Jul 2018
- First submitted
- 1 Jul 2011
- Last updated
- 12 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 16 Week Evaluation of the Novartis Health Management Tool in Assessing Self-test Visual Function in Patients With AMD Treated With Ranibizumab
- ClinicalTrials.gov ID
- NCT01542866
- Acronym / sponsor ID
- CRFB002A2407
- Conditions
- Age Related Macular Degeneration (AMD)
- Keywords
- ranibizumab, Age related Macular Degeneration, AMD, Health Management Tool, HMT, Best Corrected Visual Acuity, Investigator's Clinical Judgement of Change, Choroidal Neovascularization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Carematix, VAS (Vital Art and Science)
- Study start
- 11 Jan 2011 (actual)
- Primary completion
- 30 Nov 2011 (actual)
- Study completion
- 30 Nov 2011 (actual)
- First posted
- 2 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home Monitoring Test | Experimental | Other: Health Management Tool (HMT)Health management tool (HMT) for measuring vision impairment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Management Tool (HMT)Mobile computing platform (ie HMT) which allows subjects to perform home monitoring tests | Other | Home Monitoring Test |
Primary outcome
Threshold value of handheld Health Management Tool (HMT) for choroidal neovascular AMD diagnosis at baseline
Time frame: 16 weeks
Identification of clinically relevant worsening of visual function in the home self testing mVT scores
Time frame: baseline to 16 weeks
9 secondary outcomes
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
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
Patient compliance and reliability of performing the home self testing using the handheld Health Management Tool (HMT)
Time frame: after 16 weeks
Correlation between absolute values of the handheld Health Management Tool (HMT) and BCVA/ central retinal subfield thickness (CRST)
Time frame: 16 weeks
Correlation of the monthly changes in handheld Health Management Tool(HMT)to those of BCVA / OCT / Clinical examination
Time frame: after 16 weeks
Correlation of diagnosis of choroidal neovascular AMD with BCVA/ central retinal subfield thickness
Time frame: baseline
Correlation of monthly changes observed with thein the investigator judgment (CJ-C) to BCVA / OCT / Clinical examination
Time frame: baseline to 16 weeks
Patient compliance with the signs and symptom questionnaire
Time frame: baseline to 16 weeks
Patient satisfaction regarding the use of the HMT
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Management Tool (HMT) in people with Age Related Macular Degeneration (AMD), run by Novartis Pharmaceuticals at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Threshold value of handheld Health Management Tool (HMT) for choroidal neovascular AMD diagnosis at baseline (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2018.