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

Retinitis Pigmentosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01860092
• Other study ID #: PM-02
• Status: Terminated
• Start date: January 2014
• Est. completion date: March 2020

Study information

• Verified date: December 2021
• Source: Second Sight Medical Products
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 53
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Retinitis
• Retinitis Pigmentosa

Locations

Country	Name	City	State
United States	Retina Consultants of Hawaii	'Aiea	Hawaii
United States	University of Michigan, Kellogg Eye Center	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	Johns Hopkins, Lions Vision Center	Baltimore	Maryland
United States	Tufts Medical Center	Boston	Massachusetts
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Retina Foundation of the Southwest	Dallas	Texas
United States	University of Colorado, Denver	Denver	Colorado
United States	Duke University Eye Center	Durham	North Carolina
United States	Stony Brook University	East Setauket	New York
United States	University of Southern California	Los Angeles	California
United States	U. of Miami, Bascom Palmer Eye Institute	Miami	Florida
United States	University of Miami Bascom Palmer Eye Institute	Miami	Florida
United States	University of Minnesota Department of Ophthalmology	Minneapolis	Minnesota
United States	Wills Eye Hospital / Mid Atlantic Retina	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Second Sight Medical Products

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety subjects have reached 2 years post-implant.	Adverse event rates with the main safety analysis performed when all visits completed	5 Years
Secondary	Visual function	Visual function means how to the eye works (e.g. visual acuity). Visual function will be measured using the following test: Square Localization, Direction of Motion and Grating Visual Acuity (GVA).In addition to these tests, a photographic flash test will be performed with the System OFF only to determine if subjects' native residual vision is bare light perception or no light perception.	5 Years
Secondary	Functional Vision	Functional vision means how subjects perform in vision-related activities of daily living. Function vision will be assessed using the Functional Low-Vision Observer Rated Assessment (FLORA). A utilization questionnaire will also be administered to track how subjects are using the Argus II System.	5 Years
Secondary	Device Reliability	Device reliability will be measured by calculating the rate of implant failure over time.	5 Years