Generation of Induced Pluripotent Stem (iPS) Cell Lines From Skin Fibroblast Cells of Participants With Age-Related Macular Degeneration
2 other identifiers
observational
187
1 country
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2018
Shorter than P25 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2017
CompletedFirst Posted
Study publicly available on registry
December 14, 2017
CompletedStudy Start
First participant enrolled
May 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2019
CompletedApril 5, 2019
March 1, 2019
10 months
December 13, 2017
April 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome is to develop a repository for iPS cells for investigators involved in vision research.
Ongoing
Secondary Outcomes (1)
Secondary outcomes include the assessment of potential therapies for the treatment of age related macular disorder (AMD).
Ongoing
Study Arms (1)
1
Participants across multiple sites with AMD from the original cohort of study participants enrolled in the AREDS2
Eligibility Criteria
100 participants across multiple sites with AMD from the original cohort of study participants will be enrolled in the AREDS2 who are returning for a 10 year in-clinic study visit and have donated DNA in the AREDS2 study
You may qualify if:
- AREDS2 participants who have provided DNA samples. A list will be generated based upon the results, picking the top GWAS results from this cohort.
- Participant must understand and sign the protocol s informed consent document.
- Participant is able to provide 20 ml blood sample.
You may not qualify if:
- \. Participant is unable to comply with study procedures.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Retina-Vitreous Associates Med Group
Beverly Hills, California, 90211, United States
Bascom Palmer Eye Institute
Miami, Florida, 33136, United States
Emory University Eye Center
Atlanta, Georgia, 30322, United States
Retina Vitreous Associates of Kentucky
Lexington, Kentucky, 40509, United States
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Elman Retina Group, P.A.
Rosedale, Maryland, 21237, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114-3096, United States
Vision Research ROPARD Foundation/Associated Retinal Consultants, Grand Rapids
Grand Rapids, Michigan, 49546, United States
Vision Research ROPARD Foundation/Associated Retinal Consultants, Novi
Novi, Michigan, 48375, United States
Charlotte Eye Ear Nose & Throat Associates
Charlotte, North Carolina, 28210, United States
Casey Eye Institute
Portland, Oregon, 97210, United States
Texas Retina Associates
Dallas, Texas, 75231, United States
John Moran Eye Center, University of Utah
Salt Lake City, Utah, 84132, United States
University of Wisconsin-Madison
Madison, Wisconsin, 53705, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Emily Y Chew, M.D.
National Eye Institute (NEI)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2017
First Posted
December 14, 2017
Study Start
May 23, 2018
Primary Completion
March 21, 2019
Study Completion
March 21, 2019
Last Updated
April 5, 2019
Record last verified: 2019-03