AMD Clinical Trial
Official title:
Generation of Induced Pluripotent Stem (iPS) Cell Lines From Skin Fibroblast Cells of Participants With Age-Related Macular Degeneration: An Ancillary Study to the Age-Related Eye Disease Study-2 (AREDS2)
Verified date | March 2019 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background:
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.
Status | Completed |
Enrollment | 187 |
Est. completion date | March 21, 2019 |
Est. primary completion date | March 21, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
- INCLUSION CRITERIA: To be eligible, the following inclusion criteria must be met, where applicable. 1. AREDS2 participants who have provided DNA samples. A list will be generated based upon the results, picking the top GWAS results from this cohort. 2. Participant must understand and sign the protocol s informed consent document. 3. Participant is able to provide 20 ml blood sample. EXCLUSION CRITERIA: A participant is not eligible if any of the following exclusion criteria are present. 1. Participant is unable to comply with study procedures. |
Country | Name | City | State |
---|---|---|---|
United States | Emory University Eye Center | Atlanta | Georgia |
United States | National Institutes of Health Clinical Center | Bethesda | Maryland |
United States | Retina-Vitreous Associates Med Group | Beverly Hills | California |
United States | Massachusetts Eye and Ear Infirmary | Boston | Massachusetts |
United States | Charlotte Eye Ear Nose & Throat Associates | Charlotte | North Carolina |
United States | Texas Retina Associates | Dallas | Texas |
United States | Vision Research ROPARD Foundation/Associated Retinal Consultants, Grand Rapids | Grand Rapids | Michigan |
United States | Retina Vitreous Associates of Kentucky | Lexington | Kentucky |
United States | University of Wisconsin-Madison | Madison | Wisconsin |
United States | Bascom Palmer Eye Institute | Miami | Florida |
United States | Vision Research ROPARD Foundation/Associated Retinal Consultants, Novi | Novi | Michigan |
United States | Casey Eye Institute | Portland | Oregon |
United States | Elman Retina Group, P.A. | Rosedale | Maryland |
United States | John Moran Eye Center, University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
National Eye Institute (NEI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome is to develop a repository for iPS cells for investigators involved in vision research. | Ongoing | ||
Secondary | Secondary outcomes include the assessment of potential therapies for the treatment of age related macular disorder (AMD). | Ongoing |
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