Age Related Macular DegenerationHMPNCT00604071
Sensitivity of the Home Macular Perimeter (HMP)
An observational study of Age Related Macular Degeneration and Choroidal Neovascularization, run by Notal Vision Ltd. at 10 sites in United States.
Trial summary
estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age Related Macular Degeneration, Choroidal Neovascularization
- How many people
- 99 participants
- Where
- 10 sitesUnited States
- Study dates
- Nov 2007to Nov 2008
- 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: 62 completed subjects with new choroidal neovascularization AMD in at least one eye
Who may be able to join
- Capable and willing to sign a consent form and participate in the study
- subjects with AMD related lesions: New onset (up to 60 days) non-treated CNV
- Age >50 years
- VA with habitual correction >20/200 in study eye
- Familiar with computer usage
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, CFP, or FA
- Any non-macular related ocular surgery performed within 3 months prior to study entry in the targeted eye
- Inability to tolerate intravenous FA
- Participation in another study with the exclusion of AREDS study
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Charlotte Eye Ear Nose & Throat
Charlotte, North Carolina, 28210
Edina Retina Consultants
Edina, Minnesota, 55435
Central Florida Retina Institute
Lakeland, Florida, 33805
Virginia Retina Center
Leesburg, Virginia, 20176
Retina Vitreous Center
New Brunswick, New Jersey, 08901
Foxman Foxman & Margolis
Northfield, New Jersey, 08225
Retina care specialists
Palm Beach Gardens, Florida, 33410
International Eye Center
Tampa, Florida, 33603
Harkness Eye institute
West New York, New Jersey, 10032
Center for Retina & Macular Disease
Winter Haven, Florida, 33880
About this study
Official title: Sensitivity of the Home Macular Perimeter (HMP) in the Detection of Visual Field Abnormalities in Patients With Choroidal Neovascularization (CNV) Secondary to Age Related Macular Degeneration (AMD)- PILOT Study
estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD
Read the detailed description
The HMP device is intended to aid patients in identifying their visual abnormalities and in addition to their own symptoms or Amsler grid use and aid in their prompt referral to eye care professional examination so clinical diagnosis can be made. As such the goal of the clinical plan is to demonstrate that patients who have CNV do demonstrate visual field abnormalities when tested with the HMP
- Keywords
- HMP, CNV, PHP, HPHP, 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | subjects with AMD related lesions: New onset (up to 60 days) non-treated CNV |
What is being measured
The primary outcome is the main question the study is designed to answer.
estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD based on PRC grading of color stereo photographs and Stereoscopic fluorescein angiogram
Measured: 3 month
Secondary outcomes (6)
Estimate the sensitivity of the HMP in identifying visual field functional defects in subjects with CNV secondary to AMD based in cases where both graders, prior to any adjudication process determined the presence of CNV
Measured: 3 month
Estimate the sensitivity of the HMP in identifying visual field functional defects in subjects with CNV secondary to AMD based on cases where both graders, prior to any adjudication process, and biomicroscopic finding determined the presence of CNV
Measured: 3 Month
Estimate the sensitivity of the HMP in identifying visual field functional defects in subjects with CNV secondary to AMD determined on biomicroscopy
Measured: 3 month
Estimate the sensitivity of the Amsler grid test in identifying functional changes in subjects with CNV secondary to AMD based on PRC grading of color stereo photographs and fluorescein angiograms.
Measured: 3 month
Estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD for each of three classifications of CNV lesions (occult, minimally classic and predominantly classic).
Measured: 3 month
Estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD which were either minimally classic or occult and where the physician elected to treatment over observation
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2008 (estimated)
- Study startNov 2007
- Primary completionSep 2008
- Study completionNov 2008
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
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Notal Vision Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neil Bressler, Prof., Principal investigator, JHMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00604071
- Sponsor's protocol ID
- HMP-V4
- Other IDs
- 20071801
- Acronym
- HMP
- Status last verified
- Apr 2015
- First submitted
- 10 Jan 2008
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity of the Home Macular Perimeter (HMP) in the Detection of Visual Field Abnormalities in Patients With Choroidal Neovascularization (CNV) Secondary to Age Related Macular Degeneration (AMD)- PILOT Study
- ClinicalTrials.gov ID
- NCT00604071
- Acronym / sponsor ID
- HMP / HMP-V4
- Keywords
- HMP, CNV, PHP, HPHP, AMD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Notal Vision Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 29 Jan 2008 (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.
estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD
Detailed description
The HMP device is intended to aid patients in identifying their visual abnormalities and in addition to their own symptoms or Amsler grid use and aid in their prompt referral to eye care professional examination so clinical diagnosis can be made. As such the goal of the clinical plan is to demonstrate that patients who have CNV do demonstrate visual field abnormalities when tested with the HMP
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –subjects with AMD related lesions: New onset (up to 60 days) non-treated CNV |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 62 completed subjects with new choroidal neovascularization AMD in at least one eye
Key inclusion criteria (5 listed)
- Capable and willing to sign a consent form and participate in the study
- subjects with AMD related lesions: New onset (up to 60 days) non-treated CNV
- Age >50 years
- VA with habitual correction >20/200 in study eye
- Familiar with computer usage
Key exclusion criteria (5 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, CFP, or FA
- Any non-macular related ocular surgery performed within 3 months prior to study entry in the targeted eye
- Inability to tolerate intravenous FA
- Participation in another study with the exclusion of AREDS 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
estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD based on PRC grading of color stereo photographs and Stereoscopic fluorescein angiogram
Time frame: 3 month
6 secondary outcomes
Estimate the sensitivity of the HMP in identifying visual field functional defects in subjects with CNV secondary to AMD based in cases where both graders, prior to any adjudication process determined the presence of CNV
Time frame: 3 month
Estimate the sensitivity of the HMP in identifying visual field functional defects in subjects with CNV secondary to AMD based on cases where both graders, prior to any adjudication process, and biomicroscopic finding determined the presence of CNV
Time frame: 3 Month
Estimate the sensitivity of the HMP in identifying visual field functional defects in subjects with CNV secondary to AMD determined on biomicroscopy
Time frame: 3 month
Estimate the sensitivity of the Amsler grid test in identifying functional changes in subjects with CNV secondary to AMD based on PRC grading of color stereo photographs and fluorescein angiograms.
Time frame: 3 month
Estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD for each of three classifications of CNV lesions (occult, minimally classic and predominantly classic).
Time frame: 3 month
Estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD which were either minimally classic or occult and where the physician elected to treatment over observation
Time frame: 3 month
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 14 Apr 2015.
- sponsor web siteLink provided by the sponsor.
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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.
Neil Bressler, Prof. principal investigator
JHMC
10 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 10 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 5 inclusion and 5 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 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD based on PRC grading of color stereo photographs and Stereoscopic fluorescein angiogram (time frame: 3 month). 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 14 Apr 2015.