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

October 3, 2016 updated by: University of Missouri-Columbia
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).

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Pepose Vision Institute
      • Columbia, Missouri, United States, 65212
        • University of Missouri-Columbia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Caucasian patients over the age of 60

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ARMD Free
Patient free of ARMD on clinical examination
ARMD Positive
Patients with evidence of ARMD on clinical examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk score from RetnaGene
Time Frame: Day 1
Risk score assigned after genetic analysis of a buccal swab by the RetnaGene (Sequenom) genetic test.
Day 1
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.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Investigators

  • Principal Investigator: Nancy Holekamp, MD, Pepose Vision Institute
  • Principal Investigator: Mathew MacCumber, MD, PhD, Rush University Medical Center
  • Principal Investigator: Arghavan Almony, MD, University of Missouri-Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

May 13, 2016

First Submitted That Met QC Criteria

May 18, 2016

First Posted (Estimate)

May 20, 2016

Study Record Updates

Last Update Posted (Estimate)

October 4, 2016

Last Update Submitted That Met QC Criteria

October 3, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1200081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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