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

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.

Study Overview

• Status: Terminated
• Conditions: Retinitis Pigmentosa

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
  • Colorado
    • Denver, Colorado, United States, 80204
      • University of Colorado, Denver
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Bascom Palmer Eye Institute
    • Miami, Florida, United States, 33136
      • U. of Miami, Bascom Palmer Eye Institute
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Hawaii
    • 'Aiea, Hawaii, United States, 96701
      • Retina Consultants of Hawaii
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins, Lions Vision Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • University of Michigan, Kellogg Eye Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Department of Ophthalmology
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic
  • New York
    • East Setauket, New York, United States, 11733
      • Stony Brook University
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Eye Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Wills Eye Hospital / Mid Atlantic Retina
  • Texas
    • Dallas, Texas, United States, 75231
      • Retina Foundation of the Southwest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Argus II Retinal Prosthesis; Patients implanted with the Argus II Retinal Prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety subjects have reached 2 years post-implant.	Adverse event rates with the main safety analysis performed when all visits completed	5 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Device Reliability	Device reliability will be measured by calculating the rate of implant failure over time.	5 Years

Collaborators and Investigators

• Sponsor: Second Sight Medical Products
• Investigators: Study Director: Jessy Dorn, PhD, Second Sight Medical Products, Inc.

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: May 14, 2013
• First Submitted That Met QC Criteria: May 20, 2013
• First Posted (Estimate): May 22, 2013

Study Record Updates

• Last Update Posted (Actual): December 23, 2021
• Last Update Submitted That Met QC Criteria: December 7, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Retinal Dystrophies; Retinitis; Retinitis Pigmentosa
• Other Study ID Numbers: PM-02

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No