View Clinical Trial (Medical Research Study)
Genetics of Age Related Maculopathy
| City: |
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Los Angeles |
| State: |
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California |
| Zip Code: |
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90095 |
| Conditions: |
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Age-related Macular Degeneration - Age-related Maculopathy |
| Purpose: |
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The original study (GARM I) has been conducted for more than 18 years at the University of
Pittsburgh Medical Center (UPMC). GARM II is a nationwide research study about age-related
macular degeneration in the next generation of adults (49 to 65 years old). The purpose of
this study is to identify the hereditary and exposure risk factors that lead to the
development of ARM (Age related maculopathy).
Participants will communicate with the research staff through a protected and confidential
website and use this website to complete a number of questionnaires during the course of the
study (see below). For genetic analyses, the participants will mail in easily self-collected
saliva samples in special containers. Eye photographs and eye health records are sent to the
research center from local sources through the Internet. Individuals are not expected to
come to UCLA in order to participate.
https://jseiclinres.jsei.ucla.edu/garm/
Participants will be expected to answer questionnaires or surveys about medical history,
ocular history and visual symptoms, family history, smoking, dietary supplements and light
exposure.
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| Study Summary: |
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Age-related macular degeneration (ARM) is a major cause of vision loss in the elderly. It is
thought that smoking and diet may contribute to the risk of developing the condition but it
is clear that heredity plays a major role. Variations in two genes, CFH and HTRA1/ARMS2,
have been found to strongly contribute to the risk of developing ARM, but there are
additional genes that influence a person's chances of having this condition and how they
will progress to vision loss. We are investigating these genetic variations that contribute
to ARM so that we can eventually understand the causes of this complex condition. We study
the genetic variations (SNPs) that are shared among ARM-affected individuals within families
as well as compare the frequencies of genetic variations in ARM-affected individuals with
those in unaffected persons who are matched in age, gender, and exposures. We are conducting
studies with the DNA from our previous cohort of research participants as well as developing
a prospective study of high-risk family members and their spouses to evaluate genetic risks
and presymptomatic retinal changes. Our long-term goals are to develop new preventive
therapies that can slow or halt the development of this disease and to be able to provide
these treatments to those who are at greatest risk before they experience vision-threatening
changes.
The goal of this study (GARM II) is to determine how the combination of genetic, dietary,
health and exposure factors such as light, diet, and smoking contributes to one's risk of
developing this condition. This is not a treatment study and does not involve any
preventive therapies or direct treatments of ARM. We aim to find some insights for future
preventive strategies through a group of people who are at a higher than normal risk for
developing ARM (because of their family history) and their partners who represent the risk
in the general population. Because ARM is a complex disease and is affected by many factors,
we also want to know how other medical conditions may be associated or not with this eye
condition.
Participants will communicate with the research staff through a protected, HIPAA-compliant
and confidential website and use this website to complete a number of questionnaires during
the course of the study. For genetic analyses, the participants will mail in easily
self-collected saliva samples in special containers. Eye photographs and eye health records
are sent to the research center from local sources through the Internet. Individuals are not
expected to come to UCLA in order to participate.
https://jseiclinres.jsei.ucla.edu/garm/
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| Criteria: |
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Inclusion Criteria:
- Individuals should have an email account and access to the Internet in order to use
the website for this study. Individuals who are unfamiliar or physically challenged
with using computers may have another person assist them with reviewing messages,
questions and entering information and making inquiries.
- ARM at-risk individuals between the ages of 49 to 65 years old who have at least one
parent either deceased or alive with diagnosis of macular degeneration. This group
includes the "third generation children" of our original GARM study.
- Individuals between the ages of 49 to 65 years old who are either a spouse or partner
of an ARM at-risk adult (those individuals described above with a parent diagnosed
with ARM).
- Individuals who have vision loss from ARM and a known family history of ARM (at least
a brother, sister, or a parent). These individuals should have at least one at-risk
child between the ages of 49 to 65 years old who is willing to participate in this
study.
Exclusion Criteria:
- Inability to give informed consent. Adaptations will be provided to allow those who
are unable to read because of vision loss to participate in the informed consent
process.(Proxy)
- For the at risk individuals and their spouses/partners, they will be excluded if they
do not have access and the ability to use a computer that is connected to the
Internet.
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| NCT ID: |
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NCT01115387 |
| Primary Contact: |
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Principal Investigator
Michael B Gorin, MD, PhD
Jules Stein Eye Institute, UCLA
Michael B Gorin, MD PhD
Phone: 310 794-5598
Email: garm@jsei.ucla.edu
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| Backup Contact: |
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Email: garm@jsei.ucla.edu
Maria C Ortube, MD
Phone: 310 794-5598
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| Location Contact: |
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Los Angeles, California 90095
United States
Michael B Gorin, MD PhD
Phone: 800-286-8581
Email: garm@jsei.ucla.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 17, 2013 |
| Modifications to this listing: |
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