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

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

Sponsors

Lead Sponsor: University of Missouri-Columbia

Source 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.

Overall Status Terminated
Start Date January 2012
Completion Date December 2012
Primary Completion Date December 2012
Study Type Observational
Primary Outcome
Measure Time Frame
Risk score from RetnaGene Day 1
Risk score from Macula Risk Day 1
Enrollment 32
Condition
Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum Age: 60 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Location
Facility:
Rush University Medical Center | Chicago, Illinois, 60612, United States
Pepose Vision Institute | Chesterfield, Missouri, 63017, United States
University of Missouri-Columbia | Columbia, Missouri, 65212, United States
Location Countries

United States

Verification Date

October 2016

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: ARMD Free

Description: Patient free of ARMD on clinical examination

Label: ARMD Positive

Description: Patients with evidence of ARMD on clinical examination

Acronym PIIR
Patient Data No
Study Design Info

Observational Model: Case-Control

Time Perspective: Prospective

Source: ClinicalTrials.gov