Generation of Induced Pluripotent Stem (iPS) Cell Lines From Skin Fibroblast Cells of Participants With Age-Related Macular Degeneration
NCT ID: NCT03372746
Last Updated: 2019-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
187 participants
OBSERVATIONAL
2018-05-23
2019-03-21
Brief Summary
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Age-related macular degeneration (AMD) is the leading cause of blindness in the United States. Currently, there is no safe way to obtain cells from the eye to study. But researchers now can turn other types of cells, like skin or blood, into induced pluripotent stem (iPS) cells. These can be grown in a lab and turned into other types of cells, like cells from the eye. This will allow researchers to understand and treat diseases of the eye such as AMD.
Objectives:
To establish a bank of samples that can be changed into other cell types, such as eye cells, to better understand diseases such as AMD. Also to test drugs in order to treat various eye diseases.
Eligibility:
People who provided DNA samples in another protocol (07-EI-0025)
Design:
Participants will be screened with their data from the previous protocol. Participants with select genetic variants will be chosen and contacted via phone.
Participants will have a punch skin biopsy. The skin will be washed. A numbing medication will be injected. A small piece of skin will be removed with a biopsy tool. The site will be covered with a dressing. They will receive instructions on how to care for the area. They will have follow-up visits if needed for clinical care for the area.
Participants may be asked to return if their first sample did not provide enough cells for the lab.
Participants sample will be developed into eye cells. The cells will be used to understand diseases and test new drugs.
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Detailed Description
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Study Population: We plan to recruit 100 participants across multiple sites with AMD from the original cohort of study participants enrolled in the AREDS2 who are returning for a 10 year in-clinic study visit and have donated DNA in the AREDS2 study. Up to two participants will be enrolled at NEI. Participants with the highest genetic burden as well as those with rare variants will be included in the population.
Design: A 520 blood sample will be collected from 350 participants with specific genetic variants that are identified prior to the start of the study. Up to 60 participants will be enrolled at NEI. All of these participants were previously enrolled in the AREDS2 protocol (07-EI-0025) and they are returning for a 10-year in-clinic study visit for further phenotyping and for assessing the long-term effects of the ARESD2 supplements. Collected samples will be used to analyze molecular mechanisms involved in disease initiation and progression. In addition, the iPS cell-derived ocular cells may be used to perform high throughput (HTP) drug screens aimed at suppressing the molecular phenotypes of the disease and to identify potential therapeutic agents for these diseases. This study will typically require only one visit by each participant.
Outcome Measures: The primary outcome is to develop a repository for iPS cells for investigators involved in vision research. Secondary outcomes include the assessment of potential therapies for the treatment of age related macular disorder (AMD). There are no specific participant-based clinical outcomes for this protocol. Participants will, in general, be seen only once for this protocol, as this is an ancillary study to the main study.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
Participants across multiple sites with AMD from the original cohort of study participants enrolled in the AREDS2
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Participant must understand and sign the protocol s informed consent document.
3. Participant is able to provide 20 ml blood sample.
Exclusion Criteria
50 Years
ALL
No
Sponsors
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National Eye Institute (NEI)
NIH
Responsible Party
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Principal Investigators
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Emily Y Chew, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Eye Institute (NEI)
Locations
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Retina-Vitreous Associates Med Group
Beverly Hills, California, United States
Bascom Palmer Eye Institute
Miami, Florida, United States
Emory University Eye Center
Atlanta, Georgia, United States
Retina Vitreous Associates of Kentucky
Lexington, Kentucky, United States
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Elman Retina Group, P.A.
Rosedale, Maryland, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
Vision Research ROPARD Foundation/Associated Retinal Consultants, Grand Rapids
Grand Rapids, Michigan, United States
Vision Research ROPARD Foundation/Associated Retinal Consultants, Novi
Novi, Michigan, United States
Charlotte Eye Ear Nose & Throat Associates
Charlotte, North Carolina, United States
Casey Eye Institute
Portland, Oregon, United States
Texas Retina Associates
Dallas, Texas, United States
John Moran Eye Center, University of Utah
Salt Lake City, Utah, United States
University of Wisconsin-Madison
Madison, Wisconsin, United States
Countries
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Other Identifiers
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18-EI-0027
Identifier Type: -
Identifier Source: secondary_id
180027
Identifier Type: -
Identifier Source: org_study_id
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