Age Related Macular DegenerationNCT00358345
PreView PHP Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization
An observational study of Age Related Macular Degeneration, run by Notal Vision Ltd. at 1 site in Israel.
Trial summary
The primary objective of this study is to assess the ability of the PreView PHP(study device)to detect newly diagnosed non-treated Choroidal Neovascularization (CNV)lesion associate with advanced Age-related Macular Degeneration (AMD) or Myopia and differentiate them from Intermediate AMD or Geographic Atrophy (GA)or… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age Related Macular Degeneration
- How many people
- 347 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2003to Sep 2007
- 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: At least 200 subjects with intermediate AMD in at least one (1) eye based on medical record review and/or clinical diagnosis and at least 200 subjects with neovascular AMD in at least one (1) eye.
Who may be able to join
- Newly diagnosed (up yo 2 months) CNV OR Intermediate AMD
- Age >50 for AMD subjects
- Age >18 for Myopic subjects
- VA 20/160 or better in the study eye
- Mental and physical ability to performed a PHP test
Who cannot join
- Evidence of macular disease other than AMD or high myopia in the study eye.
- Previous surgical or laser treatment within the macular erea.
- Concurrent intraocular drug therapy (within 30 days).
- Present of any significant media opacity that preclude a clear veiw of the macula.
- Any non macular related ocular surgery performed within 3 months prior to the study.
- CNV subjects inability to tolerate intravenous fluorscien angiography.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PHP Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization
The primary objective of this study is to assess the ability of the PreView PHP(study device)to detect newly diagnosed non-treated Choroidal Neovascularization (CNV)lesion associate with advanced Age-related Macular Degeneration (AMD) or Myopia and differentiate them from Intermediate AMD or Geographic Atrophy (GA)or patients with high Myopia with no CNV.
This study secondary is to enhance NotalVision normative database.
Read the detailed description
- The study is prospective, multi-center, comparative study.
- A clinical trail with FDA approval device (510K).
- Conditions
- Age Related Macular Degeneration
- Keywords
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Intermediate AMD | |
| 2 | Newly diagnosed CNV |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2006 (estimated)
- Study startOct 2003
- Study completionSep 2007
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
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Notal Vision Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ofer Sharon, MD, Study director, Notal Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00358345
- Sponsor's protocol ID
- PHP C9
- Status last verified
- Jan 2008
- First submitted
- 27 Jul 2006
- Last updated
- 15 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHP Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization
- ClinicalTrials.gov ID
- NCT00358345
- Acronym / sponsor ID
- PHP C9
- Conditions
- Age Related Macular Degeneration
- Keywords
- AMD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Notal Vision Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2003
- Study completion
- Sep 2007 (actual)
- First posted
- 31 Jul 2006 (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 primary objective of this study is to assess the ability of the PreView PHP(study device)to detect newly diagnosed non-treated Choroidal Neovascularization (CNV)lesion associate with advanced Age-related Macular Degeneration (AMD) or Myopia and differentiate them from Intermediate AMD or Geographic Atrophy (GA)or patients with high Myopia with no CNV.
This study secondary is to enhance NotalVision normative database.
Detailed description
- The study is prospective, multi-center, comparative study.
- A clinical trail with FDA approval device (510K).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Intermediate AMD |
| 2 | – | –Newly diagnosed CNV |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- At least 200 subjects with intermediate AMD in at least one (1) eye based on medical record review and/or clinical diagnosis and at least 200 subjects with neovascular AMD in at least one (1) eye.
Key inclusion criteria (5 listed)
- Newly diagnosed (up yo 2 months) CNV OR Intermediate AMD
- Age >50 for AMD subjects
- Age >18 for Myopic subjects
- VA 20/160 or better in the study eye
- Mental and physical ability to performed a PHP test
Key exclusion criteria (6 listed)
- Evidence of macular disease other than AMD or high myopia in the study eye.
- Previous surgical or laser treatment within the macular erea.
- Concurrent intraocular drug therapy (within 30 days).
- Present of any significant media opacity that preclude a clear veiw of the macula.
- Any non macular related ocular surgery performed within 3 months prior to the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 15 Jan 2008.
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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.
Ofer Sharon, MD study director
Notal Vision
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 5 inclusion and 6 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 15 Jan 2008. 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.
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 15 Jan 2008.