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

Terminated

• Conditions: Age-Related Macular Degeneration (ARMD)

• Registration Number: NCT02779686
• Lead Sponsor: University of Missouri-Columbia

Brief 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).

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 Timeline

• Study Start: 2012-01
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2016-05-13
• Study First Submitted QC: 2016-05-18
• Study First Posted: 2016-05-20
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-03
• Last Update Posted: 2016-10-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Risk score from RetnaGene	Day 1	Risk score assigned after genetic analysis of a buccal swab by the RetnaGene (Sequenom) genetic test.
Risk score from Macula Risk	Day 1	Risk score assigned after genetic analysis of a buccal swab by the Macula Risk genetic test.

Trial Locations

Locations (3)

Pepose Vision Institute; 🇺🇸 Chesterfield, Missouri, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

University of Missouri-Columbia; 🇺🇸 Columbia, Missouri, United States