1. Prior to GARM II there was a GARM I study. Tell us a little about GARM I - what the study was about and what conclusions were made.
The intention of the GARM I study is to determine what variations in a person’s genetic information can lead to either an increased or decreased risk in developing ARM.
2. Tell us about GARM II. How is it different from GARM I?
We have learned a fair amount about several genes and changes in those genes that contribute to the risk of developing ARM. In some cases, these changes increase the risk, while others seem to be protective.
However, even using all of our current knowledge of ARM genetics we still do not have enough information to provide a person with their personal risk based on their genetics, exposures, and diet before they develop significant evidence of the condition.
Genetic testing at this time is too imperfect and thus with GARM II, we will combine genetic information with additional clinical information (such as diet, smoking history, medication history and early changes in the eye exam) to develop a better and useful method to predict a person’s risk.
3. What are you hoping to learn from the GARM II study?
With the GARM II study, we hope to find the combination of factors that can provide a person’s ARM-developing risk profile
and we hope to discover 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).
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.
4. Who is eligible to be in the macular degeneration study?
We are looking for three main groups of people.
(1) Those who have least one parent with vision loss from ARM or another relative (an aunt or uncle) who also suffers from this condition and fall between the ages of 49 and 65.
(2) Those who are the spouse and/or partner of a person who is in the preceding group, and also falls between the ages of 49 and 65.
(3) Those who have experienced vision loss from ARM regardless of their age, but who should not have experienced serious vision loss in either eye from macular degeneration before the age of 60.
5. Does a person need to live in California to participate?
Our participants live all over the country.
We correspond by mail, email, and our group will make arrangements for you to visit a nearby eye clinic for you to take your fundus photos.
All study activities are free of charge to you.
6. What is expected of the study participant?
After our participants sign the consent forms,
(1) They will take a set of retinal fundus photos at the start of the study, two years, and four years thereafter;
(2) Will fill out critical surveys at the start of the study, and repeat some of them, every 6 months thereafter, for 5 years;
(3) Will submit a saliva sample for a DNA analysis and in some cases, they may need to submit a second sample.
7. How long does the study go for?
Participants who have ARM will fulfill their participation requirements in an estimated 6 weeks. Participants who are children of those afflicted with ARM or the spouses will fulfill their participation requirements in an estimated 5 years.
8. When the study is completed, how does a participant learn about the conclusion and study results?
We will provide you with a summary of the major findings of this study in the future (through electronic newsletters) but with no individual-specific information. We will try to provide these updates on a regular basis during the study, but these will be contingent on the research resources at that time. Past and future publications related to our study may be found on websites like clinicaltrials.gov and pubmed.org.
9. If someone is interested in the study how do they contact a study coordinator?
If you want to learn more about our study, please:
1. Visit our website at www.clinicaltrials.gov
2. Phone-a-Coordinator at (800) 286-8581, or
3. Email-a-Coordinator at firstname.lastname@example.org
My husband and I are both participating in the GARM II Study, even though it is out of Jules Stein Institute in Los Angeles. That's because you don't need to live there to participate.
The study consists of completing several questionnaires on line, providing a saliva sample, and taking fundus photographs with a local ophthalmologist.
The questionnaires are east to fill out. Information about one's medical history, vision symptoms, family history, smoking, dietary supplements and light exposure is collected. Your participation may help future generations.
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