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

NCT01860092 | Terminated DMC

• 1 other identifier: PM-02
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 17

Brief Summary

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.

Conditions

Retinitis Pigmentosa

Outcome Measures

Primary Outcomes (1)

• Safety subjects have reached 2 years post-implant.

  Adverse event rates with the main safety analysis performed when all visits completed

  5 Years

Secondary Outcomes (3)

• Visual function

  5 Years

• Functional Vision

  5 Years

• Device Reliability

  5 Years

Study Arms (1)

Argus II Retinal Prosthesis

Patients implanted with the Argus II Retinal Prosthesis

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Age 25 years or older; both males and females; with severe to profound retinitis pigmentosa; with bare or no light perception in both eyes or with retinal response to electrical stimulation; with previous history of useful form vision

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Second Sight Medical Products: lead

Study Sites (17)

University of Southern California

Los Angeles, California, 90033, United States

Location

University of Colorado, Denver

Denver, Colorado, 80204, United States

Location

U. of Miami, Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

University of Miami Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Retina Consultants of Hawaii

‘Aiea, Hawaii, 96701, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Johns Hopkins, Lions Vision Center

Baltimore, Maryland, 21287, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

University of Michigan, Kellogg Eye Center

Ann Arbor, Michigan, 48105, United States

Location

University of Minnesota Department of Ophthalmology

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Stony Brook University

East Setauket, New York, 11733, United States

Location

Duke University Eye Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Wills Eye Hospital / Mid Atlantic Retina

Philadelphia, Pennsylvania, 19107, United States

Location

Retina Foundation of the Southwest

Dallas, Texas, 75231, United States

Location

Related Publications (2)

• Yue L, Wuyyuru V, Gonzalez-Calle A, Dorn JD, Humayun MS. Retina-electrode interface properties and vision restoration by two generations of retinal prostheses in one patient-one in each eye. J Neural Eng. 2020 Apr 9;17(2):026020. doi: 10.1088/1741-2552/ab7c8f.

  PMID: 32131056 DERIVED

• Gregori NZ, Callaway NF, Hoeppner C, Yuan A, Rachitskaya A, Feuer W, Ameri H, Arevalo JF, Augustin AJ, Birch DG, Dagnelie G, Grisanti S, Davis JL, Hahn P, Handa JT, Ho AC, Huang SS, Humayun MS, Iezzi R Jr, Jayasundera KT, Kokame GT, Lam BL, Lim JI, Mandava N, Montezuma SR, Olmos de Koo L, Szurman P, Vajzovic L, Wiedemann P, Weiland J, Yan J, Zacks DN. Retinal Anatomy and Electrode Array Position in Retinitis Pigmentosa Patients After Argus II Implantation: An International Study. Am J Ophthalmol. 2018 Sep;193:87-99. doi: 10.1016/j.ajo.2018.06.012. Epub 2018 Jun 27.

  PMID: 29940167 DERIVED

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jessy Dorn, PhD

  Second Sight Medical Products, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2013
• First Posted: May 22, 2013
• Study Start: January 1, 2014
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: December 23, 2021

Record last verified: 2021-12

Locations

US (17)