Age-related Macular DegenerationNCT01337414
Tools to Optimize Patient Presentation After Onset of Exudative Age-Related Macular Degeneration (AMD)
A study testing VMS diary booklet in people with Age-related Macular Degeneration, run by Johns Hopkins University at 1 site in United States.
Trial summary
Exudative age-related macular degeneration ("wet" AMD) continues to be a leading cause of central vision loss in the US for those over fifty years of age, despite the availability of several effective interventions to contain damaging neovascularization (new, abnormal blood vessel growth). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Age-related Macular Degeneration
- What is being tested?
- VMS diary booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2010to 26 Mar 2015
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects with a confirmed diagnosis of AREDS grade 3 or 4 AMD in at least one eye will be recruited for components 1 and 2 of the study. The participants will include healthy adults who are willing and able to complete the study tests. We will recruit AMD patients across a wide range of races and ages, but due to the prevalence of AMD, most of the patients will be Caucasian and over age 55. We will verify ocular diagnosis and visual function status of all subjects through records and communication provided by their retinal specialist.
Who cannot join
- Subjects with vision loss due to ocular pathology other than AMD or cataracts will be excluded.
- Subjects with cataract extraction in the last 3 months or capsulotomy in the last 24 hours in either eye will also be excluded, as well as those who are unable to give informed consent, non-English speaking or unable complete any other required study procedure.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University Wilmer Eye Institute
Baltimore, Maryland, 21205
About this study
Official title: Tools to Optimize Patient Presentation After Onset of Exudative AMD (Using the VMS Interactive Education and Early Detection Multi-Test)
Exudative age-related macular degeneration ("wet" AMD) continues to be a leading cause of central vision loss in the US for those over fifty years of age, despite the availability of several effective interventions to contain damaging neovascularization (new, abnormal blood vessel growth). The effectiveness of treatments is challenged by patients' lack of ability to recognize the need for urgent care between regular office visits. The Amsler and Yanuzzi tests, the only widely used self-tests for AMD, have proven largely ineffective at enabling patients to recognize the signs that they should consult their retina specialist for treatment.
For optimal benefit, patients should be able to self-monitor their vision over time and detect changes that may be indicative of an exudative event. To facilitate compliance these observations should be part of a larger and more engaging program of AMD awareness and self-monitoring. Among the principal shortcomings of the current "gold-standard" Amsler grid are periodicity of the test pattern and lack of individual adjustment, and therefore the reliability and accuracy of this test are less than optimal for the detection of exudative retinal changes in AMD patients. In phase I of the current study, the investigatorsW developed and evaluated several versions of improved grids, both on paper and on the Internet. These patent-pending Visual and Memory Stimulating (VMS) grids proved at least equivalent to the Amsler grid in facilitating a substantial degree of recall of prior measurements, necessary for monitoring vision over time. Adjustment features were incorporated in the on-line version to allow patients to customize their grid to their particular visual field. In the phase II study the use of VMS grids will be supplemented by a test booklet that contains educational materials and diary based survey questions in addition to the printed VMS grids; the effectiveness of this booklet for self-monitoring will be compared the standard of care (Amsler grid).
Goal of the study is to demonstrate that use of the test booklet leads to more rapid identification of newly developing vision problems, earlier diagnosis and treatment of incipient wet AMD that should result in fewer people losing their vision and less severe losses of vision.
- Conditions
- Age-related Macular Degeneration
- Being tested
- VMS diary booklet, Standard of Care
- Keywords
- age-related macular degeneration, screening, monitoring, diagnosis, dry or non-neovascular age-related macular degeneration (high risk, intermediate, geographic atrophy or AREDS grade 3/4 AMD)
- Medical subject headings
- Macular Degeneration, Disease, Geographic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VMS diary bookletBehavioural
Standard of CareBehavioural
| Study group | Role | What they receive |
|---|---|---|
| VMS diary booklet | Experimental | Not described Receives: Behavioral: VMS diary booklet |
| Usual Care (e.g. Amsler grid monitoring) | Active comparator | Not described Receives: Behavioral: Standard of Care |
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)
- Study start1 May 2010
- Primary completion26 Mar 2015
- Study completion26 Mar 2015
Why it stopped: Lack of financial support
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.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patient education and self-monitoring vs. customary care
- Masking
- None (open label)
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Results Group LLC, National Eye Institute (NEI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337414
- Sponsor's protocol ID
- NA_00016895
- Other IDs
- 2R44EY018990-02
- Status last verified
- Aug 2019
- First submitted
- 15 Apr 2011
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tools to Optimize Patient Presentation After Onset of Exudative AMD (Using the VMS Interactive Education and Early Detection Multi-Test)
- ClinicalTrials.gov ID
- NCT01337414
- Acronym / sponsor ID
- NA_00016895
- Conditions
- Age-related Macular Degeneration
- Keywords
- age-related macular degeneration, screening, monitoring, diagnosis, dry or non-neovascular age-related macular degeneration (high risk, intermediate, geographic atrophy or AREDS grade 3/4 AMD)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of financial support
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Results Group LLC, National Eye Institute (NEI)
- Study start
- 1 May 2010 (actual)
- Primary completion
- 26 Mar 2015 (actual)
- Study completion
- 26 Mar 2015 (actual)
- 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.
Exudative age-related macular degeneration ("wet" AMD) continues to be a leading cause of central vision loss in the US for those over fifty years of age, despite the availability of several effective interventions to contain damaging neovascularization (new, abnormal blood vessel growth). The effectiveness of treatments is challenged by patients' lack of ability to recognize the need for urgent care between regular office visits. The Amsler and Yanuzzi tests, the only widely used self-tests for AMD, have proven largely ineffective at enabling patients to recognize the signs that they should consult their retina specialist for treatment.
For optimal benefit, patients should be able to self-monitor their vision over time and detect changes that may be indicative of an exudative event. To facilitate compliance these observations should be part of a larger and more engaging program of AMD awareness and self-monitoring. Among the principal shortcomings of the current "gold-standard" Amsler grid are periodicity of the test pattern and lack of individual adjustment, and therefore the reliability and accuracy of this test are less than optimal for the detection of exudative retinal changes in AMD patients. In phase I of the current study, the investigatorsW developed and evaluated several versions of improved grids, both on paper and on the Internet. These patent-pending Visual and Memory Stimulating (VMS) grids proved at least equivalent to the Amsler grid in facilitating a substantial degree of recall of prior measurements, necessary for monitoring vision over time. Adjustment features were incorporated in the on-line version to allow patients to customize their grid to their particular visual field. In the phase II study the use of VMS grids will be supplemented by a test booklet that contains educational materials and diary based survey questions in addition to the printed VMS grids; the effectiveness of this booklet for self-monitoring will be compared the standard of care (Amsler grid).
Goal of the study is to demonstrate that use of the test booklet leads to more rapid identification of newly developing vision problems, earlier diagnosis and treatment of incipient wet AMD that should result in fewer people losing their vision and less severe losses of vision.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patient education and self-monitoring vs. customary care
| Arm | Type | Receives |
|---|---|---|
| VMS diary booklet | Experimental | Behavioral: VMS diary booklet |
| Usual Care (e.g. Amsler grid monitoring) | Active comparator | Behavioral: Standard of Care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with a confirmed diagnosis of AREDS grade 3 or 4 AMD in at least one eye will be recruited for components 1 and 2 of the study. The participants will include healthy adults who are willing and able to complete the study tests. We will recruit AMD patients across a wide range of races and ages, but due to the prevalence of AMD, most of the patients will be Caucasian and over age 55. We will verify ocular diagnosis and visual function status of all subjects through records and communication provided by their retinal specialist.
Key exclusion criteria (2 listed)
- Subjects with vision loss due to ocular pathology other than AMD or cataracts will be excluded.
- Subjects with cataract extraction in the last 3 months or capsulotomy in the last 24 hours in either eye will also be excluded, as well as those who are unable to give informed consent, non-English speaking or unable complete any other required study procedure.
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 |
|---|---|---|
| VMS diary booklet | Behavioural | VMS diary booklet |
| Standard of Care | Behavioural | Usual Care (e.g. Amsler grid monitoring) |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Lack of financial support). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VMS diary booklet in people with Age-related Macular Degeneration, run by Johns Hopkins University 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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 14 Aug 2019. 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 was stopped early (reason given: Lack of financial support). Results are not available in the source record.
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 14 Aug 2019.