Age Related Macular DegenerationForesee HomeNCT01010997
Foresee Home for Monitoring Age Related Macular Degeneration (AMD)
An observational study of Age Related Macular Degeneration, run by Notal Vision Ltd. at 1 site in Israel.
Trial summary
The FORESEE HOME is intended for the early detection of central and paracentral irregularities (abnormalities) in the visual field, most commonly associated with AMD. However, the device has ability to detect the development of the lesion post treatment and therefore to asses in determination of the next treatment. 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
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2009to Jan 2012
- 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: AMD subjects
Who may be able to join
- Capable and willing to sign a consent form and participate in the study
- Subjects diagnosed as CNV under treatment or Intermediate AMD in at least one eye
- Did not perform more then 10 anti- VEGF injections
- Age >50 years
- VA with habitual correction >6/45 in the study eye
- Computer users
Who cannot join
- Evidence of macular disease other than AMD or glaucoma in the study eye
- Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy,
- Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye
Trial locations and contacts
1 site in 1 country.
About this study
The FORESEE HOME is intended for the early detection of central and paracentral irregularities (abnormalities) in the visual field, most commonly associated with AMD. However, the device has ability to detect the development of the lesion post treatment and therefore to asses in determination of the next treatment.
Read the detailed description
The FORESEE HOME is intended for the early detection of central and paracentral irregularities (abnormalities) in the visual field, most commonly associated with AMD. However, the device has ability to detect the development of the lesion post treatment and therefore to asses in determination of the next treatment.
The OCT May be use as well to identify choroidal neovascularization (CNV). Comparison between the two methods will allow better understanding of both devices.
The FORESEE HOME can use as an assessment tool for the progression and success of the treatment given to AMD lesions. Therefore, evaluation the size and the location of the treated lesions may serve as an additional tool.
- Conditions
- Age Related Macular Degeneration
- Being tested
- Foresee Home
- Keywords
- AMD, CNV
- 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.
Foresee HomeDevice
using the Foresee home device
| Study group | Role | What they receive |
|---|---|---|
| Dry AMD | Intermediate AMD subjects Receives: Device: Foresee Home | |
| Wet - treated AMD | AMD subjects under treatments Receives: Device: Foresee Home |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the FORESEE HOME ability to diagnose AMD in different stages
Measured: 1 year
Secondary outcomes (1)
To investigate the correlation between visual fields (VF) defects map generated by the FORESEE HOME and features of the choroidal neovascular lesions (CNV) demonstrated by Optical Coherence Tomography(OCT).
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 posted10 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionJan 2012
- Study completionJan 2012
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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Notal Vision Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eliezer Kraus, MD, Principal investigator, Naharia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010997
- Sponsor's protocol ID
- FORESEE HOME- 02
- Other IDs
- 75909
- Acronym
- Foresee Home
- Status last verified
- Jul 2012
- First submitted
- 8 Nov 2009
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foresee Home for Monitoring Age Related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT01010997
- Acronym / sponsor ID
- Foresee Home / FORESEE HOME- 02
- Conditions
- Age Related Macular Degeneration
- Keywords
- AMD, CNV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Notal Vision Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 10 Nov 2009 (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 FORESEE HOME is intended for the early detection of central and paracentral irregularities (abnormalities) in the visual field, most commonly associated with AMD. However, the device has ability to detect the development of the lesion post treatment and therefore to asses in determination of the next treatment.
Detailed description
The FORESEE HOME is intended for the early detection of central and paracentral irregularities (abnormalities) in the visual field, most commonly associated with AMD. However, the device has ability to detect the development of the lesion post treatment and therefore to asses in determination of the next treatment.
The OCT May be use as well to identify choroidal neovascularization (CNV). Comparison between the two methods will allow better understanding of both devices.
The FORESEE HOME can use as an assessment tool for the progression and success of the treatment given to AMD lesions. Therefore, evaluation the size and the location of the treated lesions may serve as an additional tool.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry AMD | – | Device: Foresee HomeIntermediate AMD subjects |
| Wet - treated AMD | – | Device: Foresee HomeAMD subjects under treatments |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- AMD subjects
Key inclusion criteria (6 listed)
- Capable and willing to sign a consent form and participate in the study
- Subjects diagnosed as CNV under treatment or Intermediate AMD in at least one eye
- Did not perform more then 10 anti- VEGF injections
- Age >50 years
- VA with habitual correction >6/45 in the study eye
Key exclusion criteria (3 listed)
- Evidence of macular disease other than AMD or glaucoma in the study eye
- Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy,
- Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye
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 Homeusing the Foresee home device | Device | Dry AMD, Wet - treated AMD |
Primary outcome
To investigate the FORESEE HOME ability to diagnose AMD in different stages
Time frame: 1 year
1 secondary outcome
To investigate the correlation between visual fields (VF) defects map generated by the FORESEE HOME and features of the choroidal neovascular lesions (CNV) demonstrated by Optical Coherence Tomography(OCT).
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 31 Jul 2012.
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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.
Eliezer Kraus, MD principal investigator
Naharia Hospital
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 Israel.
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 6 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 31 Jul 2012. 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 Israel. 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?
To investigate the FORESEE HOME ability to diagnose AMD in different stages (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 31 Jul 2012.