Age Related Macular DegenerationCNVNCT01334294
Home Vision Monitoring Using the ForeseeHome Device Following Treatment of Neovascular Age Related Macular Degeneration
An observational study of Age Related Macular Degeneration and Choroidal Neovascularization, run by Notal Vision Ltd. at 3 sites in United States.
Trial summary
ForeseeHome, an FDA-approved home device, was specifically designed for unsupervised Preferential-Hyperacuity-Perimeter (PHP) testing of Age Related Macular Degeneration (AMD) patients at home by characterizing central and paracentral metamorphopsia . Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Age Related Macular Degeneration, Choroidal Neovascularization
- What is being tested?
- ForeseeHome
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2011to Mar 2014
- Phase
- Observational
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Wet AMD
Who may be able to join
- Received intravitreal antiangiogenic therapy for CNV in the study eye (SE), within 2-12 months prior to the study
- Last diagnosis was, and current diagnosis is, no CNV activity in SE eye
- Current plan in SE is clinical examination as standard care but at intervals of not more than 8 weeks.
- Visual acuity of 20/80 or better in SE
- Are capable and agree to sign a consent form and participate in the study
- Age > 55 year of age
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- Are able to use a standard computer mouse correctly and without assistance
- Have a working telephone landline at the main residence (cellular communication maybe available for the study, and then eliminate this requirement)
- Clear view of the macular area on fundus photography
- Are willing to give their name and contact information to Notal Vision, supplier of the device, so that the company can provide direct services if needed (e.g., assist in using the home device, report the frequency of usage, coordinate replacement of devices in case of a technical problems, etc.)
- Agree to be examined by an ophthalmologist if SE shows symptoms of changes during the study
- Have a US address and do not plan on traveling abroad during the study period
- Fluent in English
- Perform a reliable ForeseeHome test during the enrollment visit
Who cannot join
- Evidence of macular disease other than AMD or glaucoma in SE
- Presence of any significant media opacity that precludes a clear view of the macular area as identified in SE by biomicroscopy
- Any non-macular related ocular surgery performed within 3 months prior to study entry in SE
- Participant are not enrolled in another stuy that could affect the interval between clinical examinations, or the frequency of use of the ForeseeHome device
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Elman retina group
Baltimore, Maryland
Retina Care specisalists
Palm Beach Gardens, Florida
Pepose Vision Institute
St Louis, Missouri
About this study
Official title: Home Vision Monitoring Using the ForeseeHome Device Following Treatment of Neovascular AMD
ForeseeHome, an FDA-approved home device, was specifically designed for unsupervised Preferential-Hyperacuity-Perimeter (PHP) testing of Age Related Macular Degeneration (AMD) patients at home by characterizing central and paracentral metamorphopsia . The purpose of the current study is to evaluate if, in post-treatment patients, PHP parameters as measured with the ForeseeHome are in agreement with clinical decisions and retinal characteristics as measured with optical coherence tomography (OCT).
- Being tested
- ForeseeHome
- Keywords
- CNV, AMD
- 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.
ForeseeHomeDevice
The ForeseeHomeTM device, was designed to identify central and paracentral irregularities (vision abnormalities) in the visual field, most commonly associated with exudative macular degeneration.
| Study group | Role | What they receive |
|---|---|---|
| 1. Received therapy for CNV | Not described Receives: Device: ForeseeHome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the accuracy of the ForeseeHome to detect reactivation of CNV following successful treatment with Anti-VEGF
Measured: 1 year
Secondary outcomes (1)
Evaluate the correlation between PHP measures and OCT measures
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular DegenerationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Notal Vision Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Michels, MD, Principal investigator, Retina care specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334294
- Sponsor's protocol ID
- PT US 001.2
- Acronym
- CNV
- Status last verified
- Oct 2014
- First submitted
- 11 Apr 2011
- Last updated
- 3 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Vision Monitoring Using the ForeseeHome Device Following Treatment of Neovascular AMD
- ClinicalTrials.gov ID
- NCT01334294
- Acronym / sponsor ID
- CNV / PT US 001.2
- Keywords
- CNV, AMD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Notal Vision Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 13 Apr 2011 (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.
ForeseeHome, an FDA-approved home device, was specifically designed for unsupervised Preferential-Hyperacuity-Perimeter (PHP) testing of Age Related Macular Degeneration (AMD) patients at home by characterizing central and paracentral metamorphopsia . The purpose of the current study is to evaluate if, in post-treatment patients, PHP parameters as measured with the ForeseeHome are in agreement with clinical decisions and retinal characteristics as measured with optical coherence tomography (OCT).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1. Received therapy for CNV | – | Device: ForeseeHome |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Wet AMD
Key inclusion criteria (14 listed)
- Received intravitreal antiangiogenic therapy for CNV in the study eye (SE), within 2-12 months prior to the study
- Last diagnosis was, and current diagnosis is, no CNV activity in SE eye
- Current plan in SE is clinical examination as standard care but at intervals of not more than 8 weeks.
- Visual acuity of 20/80 or better in SE
- Are capable and agree to sign a consent form and participate in the study
Key exclusion criteria (4 listed)
- Evidence of macular disease other than AMD or glaucoma in SE
- Presence of any significant media opacity that precludes a clear view of the macular area as identified in SE by biomicroscopy
- Any non-macular related ocular surgery performed within 3 months prior to study entry in SE
- Participant are not enrolled in another stuy that could affect the interval between clinical examinations, or the frequency of use of the ForeseeHome device
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 |
|---|---|---|
| ForeseeHomeThe ForeseeHomeTM device, was designed to identify central and paracentral irregularities (vision abnormalities) in the visual field, most commonly associated with exudative macular degeneration. | Device | 1. Received therapy for CNV |
Primary outcome
Assess the accuracy of the ForeseeHome to detect reactivation of CNV following successful treatment with Anti-VEGF
Time frame: 1 year
1 secondary outcome
Evaluate the correlation between PHP measures and OCT measures
Time frame: 1 year
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 3 Oct 2014.
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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.
Mark Michels, MD principal investigator
Retina care specialists
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age Related Macular Degeneration and Choroidal Neovascularization, run by Notal Vision Ltd. at 3 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 14 inclusion and 4 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 3 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Assess the accuracy of the ForeseeHome to detect reactivation of CNV following successful treatment with Anti-VEGF (time frame: 1 year). 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 3 Oct 2014.