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

Age-Related Macular Degeneration (ARMD) Clinical Trial

— PIIR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02779686
• Other study ID #: 1200081
• Status: Terminated
• Phase: N/A
• First received: May 13, 2016
• Last updated: October 3, 2016
• Start date: January 2012
• Est. completion date: December 2012

Study information

• Verified date: October 2016
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Age-Related Macular Degeneration (ARMD)
• Macular Degeneration

Locations

Country	Name	City	State
United States	Pepose Vision Institute	Chesterfield	Missouri
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Missouri-Columbia	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk score from RetnaGene	Risk score assigned after genetic analysis of a buccal swab by the RetnaGene (Sequenom) genetic test.	Day 1	No
Primary	Risk score from Macula Risk	Risk score assigned after genetic analysis of a buccal swab by the Macula Risk genetic test.	Day 1	No

External Links

•   Macula Risk product/test information
•   RetnaGene product/test information