New Enrollment Post-Approval Study of the Argus® II Retinal Prosthesis System



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:25 - Any
Updated:7/25/2018
Start Date:January 2014
End Date:December 2023
Contact:Jessy Dorn, PhD
Email:patients@2-sight.com
Phone:855-756-3703

Use our guide to learn which trials are right for you!

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.

Safety data will be monitored to ensure continued acceptability of risks to study subjects.
The utility (i.e. visual function and functional vision) and reliability of Argus II System
will also be evaluated.

There is no study hypothesis.

Inclusion Criteria:

- Are adults, age 25 year or older;

- Have severe to profound retinitis pigmentosa;

- Bare light or no light perception in both eyes; if the patient has no residual light
perception, then evidence of intact inner layer retina function must be confirmed;

- Have previous history of useful form vision.

- Aphakic or pseudophakic. (If the patient is phakic prior to implant, the natural lens
will be removed during the implant procedure.)

- Patients who are willing and able to receive the recommended post-implant clinical
follow-up, device fitting, and visual rehabilitation;

- Have consented to the implantation of an Argus II Retinal Prosthesis and subsequently
consent to participate in this study;

- At the time of the Baseline Visit, do not suffer from non-ophthalmic serious adverse
events (e.g. myocardial infarction, etc.) and

Exclusion Criteria:

- Ocular diseases or conditions that could prevent Argus II System from working (e.g.
optic nerve disease, central retinal artery or vein occlusion, history of retinal
detachment, trauma, severe strabismus);

- Ocular structures or conditions that could prevent the successful implantation of the
Argus II Implant or adequate healing from surgery (e.g. extremely thin conjunctiva,
axial length <20.5 mm or >26 mm, corneal ulcers, etc.);

- Ocular diseases or conditions (other than cataracts) that prevent adequate
visualization of the inner structures of the eye (e.g. corneal opacity, etc.);

- Inability to tolerate general anesthesia or the recommended antibiotic and steroid
regimen associated with the implantation surgery;

- Metallic or active implantable device(s) (e.g. cochlear implant) in the head;

- Pre-disposition to eye rubbing;

- Any disease or condition that prevents understanding or communication of informed
consent, study demands, and testing protocols, including:

- cognitive decline including diagnosed forms of dementia and/or progressive
neurologic disease,

- psychiatric disease including diagnosed forms of depression;

- does not speak a principal language associated with the region, and

- deafness;

- Pregnant or wish to become pregnant during the course of the study;

- Participating in another investigational drug or device study that may conflict with
the objectives, follow-up or testing of this study;

- Conditions likely to limit life to less than 1 year from the time of inclusion.
We found this trial at
17
sites
Ann Arbor, Michigan 48105
Principal Investigator: Thiran Jayasundera, MD FACS
Phone: 734-936-8638
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Jiong Yan, MD
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Alex Yuan, MD, PhD
Phone: 216-445-7671
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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Los Angeles, California 90033
213) 740-2311
Principal Investigator: Lisa Olmos, MD
Phone: 323-442-6490
University of Southern California The University of Southern California is one of the world’s leading...
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98-1079 Moanalua Road
'Aiea, Hawaii 96701
Principal Investigator: Gregg Kokame, MD
Phone: 808-380-8060
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'Aiea, HI
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Baltimore, Maryland 21287
Principal Investigator: Gislin Dagnelie, PhD
Phone: 443-287-0072
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Baltimore, MD
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Boston, Maryland 02111
Principal Investigator: Michelle Liang, MD
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Boston, MD
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
Principal Investigator: Jennifer Lim, MD
Phone: 312-355-3743
University of Illinois at Chicago A major research university in the heart of one of...
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Chicago, IL
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Dallas, Texas 75231
Principal Investigator: David Birch, PhD
Phone: 214-363-3911
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Denver, Colorado 80291
Principal Investigator: Naresh Mandava, MD
Phone: 720-848-2035
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Durham, North Carolina 27710
Principal Investigator: Paul Hahn, MD, PhD
Phone: 919-684-9072
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East Setauket, New York 11733
Principal Investigator: Khurram Chaudhary, MD
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Miami, Florida 33136
Principal Investigator: Byron Lam, MD
Phone: 305-202-4731
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Miami, Florida
Principal Investigator: Byron Lam, MD
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Minneapolis, Minnesota 55455
Principal Investigator: Sandra Montezuma, MD
Phone: 612-626-3056
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Philadelphia, Pennsylvania 19107
Principal Investigator: Allen Ho, MD
Phone: 215-928-3092
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Rochester, Minnesota 55905
Principal Investigator: Raymond Iezzi, MD
Phone: 507-284-5833
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