PIIR Study: Comparison of Genetic Tests for Age-Related Macular Degeneration

NCT ID: NCT02779686

Last Updated: 2016-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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

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Age-Related Macular Degeneration (ARMD)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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ARMD Free

Patient free of ARMD on clinical examination

No interventions assigned to this group

ARMD Positive

Patients with evidence of ARMD on clinical examination

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Caucasian race
* Age \>/= 60 years
* Patient's written informed consent
* Ability to comply with the protocol procedures

Exclusion Criteria

* 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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nancy Holekamp, MD

Role: PRINCIPAL_INVESTIGATOR

Pepose Vision Institute

Mathew MacCumber, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Arghavan Almony, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

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Rush University Medical Center

Chicago, Illinois, United States

Site Status

Pepose Vision Institute

Chesterfield, Missouri, United States

Site Status

University of Missouri-Columbia

Columbia, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19117936 (View on PubMed)

Hageman 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.

Reference Type BACKGROUND
PMID: 21807600 (View on PubMed)

Zanke 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.

Reference Type BACKGROUND
PMID: 20130705 (View on PubMed)

Related Links

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http://www.sequenom.com

RetnaGene product/test information

http://www.macularisk.com

Macula Risk product/test information

Other Identifiers

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1200081

Identifier Type: -

Identifier Source: org_study_id

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