Age Related Macular DegenerationNCT01336907
Comparison Between Home Macular Perimeter and Optical Coherence Tomography (OCT) Visual Field Defects in Patients With Choroidal Neovascularization (CNV)
An observational study of Age Related Macular Degeneration and Choroidal Neovascularization, run by Notal Vision Ltd. at 1 site in France.
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 Age Related Macular Degeneration (AMD). 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
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Start not givento not given
- 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: CNV subjects
Who may be able to join
- For naïve CNV lesion - diagnosed in less than 60 days. OR For re-activated CNV lesion - treated more than 4 month from the diagnosis.
- Intent to treat the study eye (SE)
- Corrected VA better than 6/45 (20/150) in SE
- Subject is capable and willing to sign a consent form and participate in the study
- Age > 55 years
- Subject declared that he or she knows how to operate a computer mouse
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 the SE by biomicroscopy
- Any ocular surgery performed within 3 months prior to study entry in the SE * Participation in another study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Home Macular Perimeter and OCT Visual Field Defects in Patients With CNV
The FORESEE HOME is intended for the early detection of central and paracentral irregularities (abnormalities) in the visual field, most commonly associated with Age Related Macular Degeneration (AMD). However, the device has the ability to detect the development of the lesion post treatment and therefore to assess in determination of the next treatment.
The Optical Coherence Tomography (OCT) may be used as well to identify choroidal neovascularization (CNV). Comparison between the two methods will allow better understanding of both devices.
The FORESEE HOME can be used as an assessment tool for the progression and success of the treatment given to AMD lesions. Therefore, evaluating the size and the location of the treated lesions may serve as an additional tool.
- Keywords
- CNV, AMD, Wet-treated 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.
| Study group | Role | What they receive |
|---|---|---|
| naive CNV subjects | Newly diagnosed CNV, before any treatment (naïve) | |
| previously diagnosed CNV subjects | Previously diagnosed CNV if last treatment is older than 4 months (reactivated) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate the correlation between features of CNV lesions as measured with SD OCT and in the ForeseeHome.
the measures are Height of Pigment Epithelial Detachment , Sub Retinal Fluid Thickness , Maximum Diameter of Largest Retinal Cyst , Maximum Retinal Thickness , Central Retinal Thickness
Measured: 3-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
Why it stopped: never started
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Notal Vision Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giuseppe Querques, Dr., Principal investigator, Department of Ophthalmology, Centre Hospitalier Intercommunal de Creteil, University Paris XII, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336907
- Sponsor's protocol ID
- HMP-DTR-01
- Status last verified
- Sep 2016
- First submitted
- 13 Apr 2011
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Home Macular Perimeter and OCT Visual Field Defects in Patients With CNV
- ClinicalTrials.gov ID
- NCT01336907
- Acronym / sponsor ID
- HMP-DTR-01
- Keywords
- CNV, AMD, Wet-treated CNV
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Notal Vision Ltd.Industry (pharma, biotech, devices)
- First posted
- 18 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.
The FORESEE HOME is intended for the early detection of central and paracentral irregularities (abnormalities) in the visual field, most commonly associated with Age Related Macular Degeneration (AMD). However, the device has the ability to detect the development of the lesion post treatment and therefore to assess in determination of the next treatment.
The Optical Coherence Tomography (OCT) may be used as well to identify choroidal neovascularization (CNV). Comparison between the two methods will allow better understanding of both devices.
The FORESEE HOME can be used as an assessment tool for the progression and success of the treatment given to AMD lesions. Therefore, evaluating 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 |
|---|---|---|
| naive CNV subjects | – | –Newly diagnosed CNV, before any treatment (naïve) |
| previously diagnosed CNV subjects | – | –Previously diagnosed CNV if last treatment is older than 4 months (reactivated) |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CNV subjects
Key inclusion criteria (6 listed)
- For naïve CNV lesion - diagnosed in less than 60 days. OR For re-activated CNV lesion - treated more than 4 month from the diagnosis.
Key exclusion criteria (3 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 the SE by biomicroscopy
- Any ocular surgery performed within 3 months prior to study entry in the SE * Participation in another 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
Investigate the correlation between features of CNV lesions as measured with SD OCT and in the ForeseeHome.
Time frame: 3-4 months
the measures are Height of Pigment Epithelial Detachment , Sub Retinal Fluid Thickness , Maximum Diameter of Largest Retinal Cyst , Maximum Retinal Thickness , Central Retinal Thickness
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
- sponsor's 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.
Giuseppe Querques, Dr. principal investigator
Department of Ophthalmology, Centre Hospitalier Intercommunal de Creteil, University Paris XII, Paris, France
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 and Choroidal Neovascularization, run by Notal Vision Ltd. at 1 site in France.
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: withdrawn, as of the sponsor's last update on 21 Sep 2016. 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 France. 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 was withdrawn before enrolling participants, so there are no results.
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?
Investigate the correlation between features of CNV lesions as measured with SD OCT and in the ForeseeHome. (time frame: 3-4 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 21 Sep 2016.