Age-Related Macular DegenerationAMDNCT01083147
Age-Related Macular Degeneration (AMD) - Beta Study Telemedicine Assessment
An observational study of Age-Related Macular Degeneration, run by Notal Vision Ltd. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the compliance of the Foresee Home device in intermediate AMD patients. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- FORESEE HOME
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Sep 2010
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: intermediate AMD
Who may be able to join
- Subjects who successfully completed participation in ForeseeHome-US2 study
- Patients with ability to comprehend and sign the informed consent/authorization
Who cannot join
- Subjects who failed to complete participation in ForeseeHome-US2 study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the compliance of the Foresee Home device in intermediate AMD patients.
Read the detailed description
This is a non-randomized cohort, multi-center study. The eligible subjects will be asked to use the FORESEE HOME device daily and the tests results will be automatically transmitted to the Data Monitor Center for analysis.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- FORESEE HOME
- Keywords
- Intermediate AMD
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FORESEE HOMEDevice
Home Monitoring
| Study group | Role | What they receive |
|---|---|---|
| Dry AMD | subjects diagnosed as intermediate AMD in at least one eye Receives: Device: FORESEE HOME |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject compliance with Foresee HomeTM device
Measured: 6 months
Secondary outcomes (1)
Assessment of the Telemedicine infrastructure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startOct 2009
- Primary completionMar 2010
- Study completionSep 2010
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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Notal Vision Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Daniel Roth, MD, Principal investigator, Vitreos retina center - NJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083147
- Sponsor's protocol ID
- ForeseeHome-US3
- Acronym
- AMD
- Status last verified
- Sep 2010
- First submitted
- 7 Mar 2010
- Last updated
- 23 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-Related Macular Degeneration (AMD) - Beta Study Telemedicine Assessment
- ClinicalTrials.gov ID
- NCT01083147
- Acronym / sponsor ID
- AMD / ForeseeHome-US3
- Conditions
- Age-Related Macular Degeneration
- Keywords
- Intermediate AMD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Notal Vision Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 9 Mar 2010 (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.
The purpose of this study is to evaluate the compliance of the Foresee Home device in intermediate AMD patients.
Detailed description
This is a non-randomized cohort, multi-center study. The eligible subjects will be asked to use the FORESEE HOME device daily and the tests results will be automatically transmitted to the Data Monitor Center for analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dry AMD | – | Device: FORESEE HOMEsubjects diagnosed as intermediate AMD in at least one eye |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- intermediate AMD
Key inclusion criteria (2 listed)
- Subjects who successfully completed participation in ForeseeHome-US2 study
- Patients with ability to comprehend and sign the informed consent/authorization
Key exclusion criteria (1 listed)
- Subjects who failed to complete participation in ForeseeHome-US2 study
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 |
|---|---|---|
| FORESEE HOMEHome Monitoring | Device | Dry AMD |
Primary outcome
Subject compliance with Foresee HomeTM device
Time frame: 6 months
1 secondary outcome
Assessment of the Telemedicine infrastructure
Time frame: 6 months
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 23 Sep 2010.
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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.
Daniel Roth, MD principal investigator
Vitreos retina center - NJ
1 site 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, run by Notal Vision Ltd. at 1 site 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 1 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 23 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Subject compliance with Foresee HomeTM device (time frame: 6 months). 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 23 Sep 2010; AzTrials last refreshed its copy on 7 Nov 2026.