Trials / NCT01860092
New Enrollment Post-Approval Study of the Argus® II Retinal Prosthesis System
Terminated Observational Natural history / observational
Why it stopped: Manufacturing ceased for all Argus II and Argus 2s devices (FDA notified of and subsequently approved discontinuation of post approval study in Oct 2021)
- Sponsor
- Second Sight Medical Products
- Treatment
- Not listed
- Gene
- Not stated
- Conditions
- Retinitis Pigmentosa
- Ages
- 25 Years to no upper limit
- Enrollment
- 53 participants
- Started
- 2014-01
- Main results expected
- 2020-03
- Results posted
- Not yet
- Record last updated
- 2021-12-23
What the study is testing
This post-approval study is being implemented to monitor the use of Argus II System in a larger US population than available within pre-approval studies. An attempt will be made to include all eligible and willing subjects implanted with Argus II System in the United States.
Where it runs
United States (17)
- University of Southern California, Los Angeles, California
- University of Colorado, Denver, Denver, Colorado
- U. of Miami, Bascom Palmer Eye Institute, Miami, Florida
- University of Miami Bascom Palmer Eye Institute, Miami, Florida
- Emory University, Atlanta, Georgia
- Retina Consultants of Hawaii, ‘Aiea, Hawaii
- University of Illinois at Chicago, Chicago, Illinois
- Johns Hopkins, Lions Vision Center, Baltimore, Maryland
- Tufts Medical Center, Boston, Massachusetts
- University of Michigan, Kellogg Eye Center, Ann Arbor, Michigan
- University of Minnesota Department of Ophthalmology, Minneapolis, Minnesota
- Mayo Clinic, Rochester, Minnesota
- Stony Brook University, East Setauket, New York
- Duke University Eye Center, Durham, North Carolina
- Cleveland Clinic, Cleveland, Ohio
- Wills Eye Hospital / Mid Atlantic Retina, Philadelphia, Pennsylvania
- Retina Foundation of the Southwest, Dallas, Texas