Age-Related Macular Degeneration (ARMD)PIIRNCT02779686
PIIR Study: Comparison of Genetic Tests for Age-Related Macular Degeneration
An observational study of Age-Related Macular Degeneration (ARMD), run by University of Missouri-Columbia at 3 sites in United States.
Trial summary
This study is being conducted to compare two different genetic tests developed to determine an individuals risk of developing serious vision threatening complications from age-related macular degeneration (ARMD). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-Related Macular Degeneration (ARMD)
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2012to Dec 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Caucasian patients over the age of 60
Who may be able to join
- Caucasian race
- Age >/= 60 years
- Patient's written informed consent
- Ability to comply with the protocol procedures
Who cannot join
- Race other than Caucasian
- Age < 60 years
- Macular or retinal pathology other than ARMD
- Known hypersensitivity to any drug included in the treatment protocol
- Any other severe clinical condition that in the judgment of the local investigator would place the patient at undue risk or interfere with the study completion
- Prisoners
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pepose Vision Institute
Chesterfield, Missouri, 63017
Rush University Medical Center
Chicago, Illinois, 60612
University of Missouri-Columbia
Columbia, Missouri, 65212
About this study
This study is being conducted to compare two different genetic tests developed to determine an individuals risk of developing serious vision threatening complications from age-related macular degeneration (ARMD).
Read the detailed description
There are currently two different genetic tests that have been developed for this purpose. They both look at specific DNA components to determine the risk. Participants in the study will be over the age of 60 years and caucasian as this is the population of people in which these tests have been validated. Each participant will have the study explained to them and then will be asked to sign the informed consent document if they agree to participate. They will have a dilated exam of their eyes along with photographs taken of the retina. If their doctor sees that it is necessary they will also have a special scan or a special angiogram of their eyes to look at their retina in more detail. For the genetic testing a member of the research team will use two swabs from each of the genetic companies to gently scrap some cells from the inside of the cheek. These cells will be sent to each respective lab for analysis.
- Conditions
- Age-Related Macular Degeneration (ARMD)
- Keywords
- Macular Degeneration, Genetic testing, Age-Related Macular degeneration, Age-Related Maculopathies
- 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 |
|---|---|---|
| ARMD Free | Patient free of ARMD on clinical examination | |
| ARMD Positive | Patients with evidence of ARMD on clinical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk score from RetnaGene
Risk score assigned after genetic analysis of a buccal swab by the RetnaGene (Sequenom) genetic test.
Measured: Day 1
Risk score from Macula Risk
Risk score assigned after genetic analysis of a buccal swab by the Macula Risk genetic test.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startJan 2012
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Investigator left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Age-Related Macular Degeneration (ARMD)Studies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy Holekamp, MD, Principal investigator, Pepose Vision InstituteMathew MacCumber, MD, PhD, Principal investigator, Rush University Medical CenterArghavan Almony, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779686
- Sponsor's protocol ID
- 1200081
- Acronym
- PIIR
- Status last verified
- Oct 2016
- First submitted
- 13 May 2016
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Seddon JM, Reynolds R, Maller J, Fagerness JA, Daly MJ, Rosner B. Prediction model for prevalence and incidence of advanced age-related macular degeneration based on genetic, demographic, and environmental variables. Invest Ophthalmol Vis Sci. 2009 May;50(5):2044-53. doi: 10.1167/iovs.08-3064. Epub 2008 Dec 30.
PubMed 19117936Hageman GS, Gehrs K, Lejnine S, Bansal AT, Deangelis MM, Guymer RH, Baird PN, Allikmets R, Deciu C, Oeth P, Perlee LT. Clinical validation of a genetic model to estimate the risk of developing choroidal neovascular age-related macular degeneration. Hum Genomics. 2011 Jul;5(5):420-40. doi: 10.1186/1479-7364-5-5-420.
PubMed 21807600Zanke B, Hawken S, Carter R, Chow D. A genetic approach to stratification of risk for age-related macular degeneration. Can J Ophthalmol. 2010 Feb;45(1):22-7. doi: 10.3129/i09-209.
PubMed 20130705
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PIIR Study: Comparison of Genetic Tests for Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT02779686
- Acronym / sponsor ID
- PIIR / 1200081
- Conditions
- Age-Related Macular Degeneration (ARMD)
- Keywords
- Macular Degeneration, Genetic testing, Age-Related Macular degeneration, Age-Related Maculopathies
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Investigator left institution
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 May 2016 (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.
This study is being conducted to compare two different genetic tests developed to determine an individuals risk of developing serious vision threatening complications from age-related macular degeneration (ARMD).
Detailed description
There are currently two different genetic tests that have been developed for this purpose. They both look at specific DNA components to determine the risk. Participants in the study will be over the age of 60 years and caucasian as this is the population of people in which these tests have been validated. Each participant will have the study explained to them and then will be asked to sign the informed consent document if they agree to participate. They will have a dilated exam of their eyes along with photographs taken of the retina. If their doctor sees that it is necessary they will also have a special scan or a special angiogram of their eyes to look at their retina in more detail. For the genetic testing a member of the research team will use two swabs from each of the genetic companies to gently scrap some cells from the inside of the cheek. These cells will be sent to each respective lab for analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARMD Free | – | –Patient free of ARMD on clinical examination |
| ARMD Positive | – | –Patients with evidence of ARMD on clinical examination |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Caucasian patients over the age of 60
Key inclusion criteria (4 listed)
- Caucasian race
- Age >/= 60 years
- Patient's written informed consent
- Ability to comply with the protocol procedures
Key exclusion criteria (6 listed)
- Race other than Caucasian
- Age < 60 years
- Macular or retinal pathology other than ARMD
- Known hypersensitivity to any drug included in the treatment protocol
- Any other severe clinical condition that in the judgment of the local investigator would place the patient at undue risk or interfere with the study completion
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
Risk score from RetnaGene
Time frame: Day 1
Risk score assigned after genetic analysis of a buccal swab by the RetnaGene (Sequenom) genetic test.
Risk score from Macula Risk
Time frame: Day 1
Risk score assigned after genetic analysis of a buccal swab by the Macula Risk genetic test.
Results and safety
The study was stopped early (reason given: Investigator left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
- Background: PubMed 19117936Seddon JM, Reynolds R, Maller J, Fagerness JA, Daly MJ, Rosner B. Prediction model for prevalence and incidence of advanced age-related macular degeneration based on genetic, demographic, and environmental variables. Invest Ophthalmol Vis Sci. 2009 May;50(5):2044-53. doi: 10.1167/iovs.08-3064. Epub 2008 Dec 30.
- Background: PubMed 21807600Hageman GS, Gehrs K, Lejnine S, Bansal AT, Deangelis MM, Guymer RH, Baird PN, Allikmets R, Deciu C, Oeth P, Perlee LT. Clinical validation of a genetic model to estimate the risk of developing choroidal neovascular age-related macular degeneration. Hum Genomics. 2011 Jul;5(5):420-40. doi: 10.1186/1479-7364-5-5-420.
- Background: PubMed 20130705Zanke B, Hawken S, Carter R, Chow D. A genetic approach to stratification of risk for age-related macular degeneration. Can J Ophthalmol. 2010 Feb;45(1):22-7. doi: 10.3129/i09-209.
- RetnaGene product/test informationLink provided by the sponsor.
- Macula Risk product/test informationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Nancy Holekamp, MD principal investigator
Pepose Vision Institute
Mathew MacCumber, MD, PhD principal investigator
Rush University Medical Center
Arghavan Almony, MD principal investigator
University of Missouri-Columbia
3 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 (ARMD), run by University of Missouri-Columbia at 3 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 4 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: stopped early, as of the sponsor's last update on 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 was stopped early (reason given: Investigator left institution). 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.
What does the primary outcome measure?
Risk score from RetnaGene (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02779686, which also lists 3 linked publications.
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 4 Oct 2016.