Argus® II Retinal Stimulation System Feasibility Protocol

January 11, 2022 updated by: Second Sight Medical Products

Investigational Phase of the Study:

The objective of this feasibility study is to evaluate the safety and utility of the Argus II Retinal Stimulation System in providing visual function to blind subjects with retinitis pigmentosa.

Post-Approval Phase of the Study:

To collect post-approval data in order to monitor the ongoing safety and reliability of the Argus II System

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During the post-approval phase, subjects will undergo annual eye exams, assessments of medical status and adverse events, and measurement of stimulation thresholds. In addition, at the mutual agreement of the investigator and the subject, subjects will have the option of participating in psychophysical research which could occur as frequently as monthly. Functional tests at 10 years: photographic flash, square localization, direction of motion and grating visual acuity.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Centre d'Investigation Clinique, Service d'Ophtalmologie, Quinze-Vingts National Eye Hospital, 28 rue de Charenton, 75557 Cedex 12
  • Mexico
    • Jalisco
      • Zapopan, Jalisco, Mexico, 51116
        • Puerta de Hierro, Centro Medico, Centro de Retina
  • Switzerland
      • Geneva, Switzerland
        • Clinique d'Ophthalmologie Hopitaux, Universitaires de Geneve 22 rue Alcide Jentzer 1205
  • United Kingdom
      • London, United Kingdom, EC1V 2PD
        • Moorfields Eye Hospital, Vitreoretinal Research Unit
      • Manchester, United Kingdom
        • Manchester Royal Eye Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Doheny Eye Institute
      • San Francisco, California, United States, 94143
        • University of California San Francisco
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins, Wilmer Eye Institute
    • New York
      • New York, New York, United States, 10032
        • Columbia University, Department of Ophthalmology, Edward S. Harkness Eye Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Wills Eye Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania, Scheie Eye Institute
    • Texas
      • Dallas, Texas, United States, 75231
        • Retina Foundation of the Southwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A confirmed history of retinitis pigmentosa (all centers) or outer retinal degeneration (France, U.K., Switzerland, Mexico only) with remaining visual acuity of bare light perception (all centers) or 2.3 logMAR (France, U.K., Switzerland, Mexico only) or worse in both eyes.
  • Functional ganglion cells and optic nerve as determined by a measurable electrically evoked response or documented light perception.
  • A history of former useful form vision in the worse-seeing eye.
  • Must be at least the following age at the time of enrollment: 25 (USA, Switzerland) or 18 (France, U.K., and Mexico) years old
  • Must reside within 2 hours (USA, UK and Mexico) or 3 hours (France and Switzerland) distance (by ground transportation) of the investigational site.
  • Must be willing and able to comply with the protocol testing and follow-up requirements.

Exclusion Criteria:

  • Optic Nerve disease

    • History of glaucoma
    • Optic neuropathy or other confirmed damage to optic nerve or visual cortex damage

  • Diseases or conditions that effect retinal function including but not limited to:

    • Central retinal artery/vein occlusion (CRAO or CRVO)
    • End-stage diabetic retinopathy
    • Retinal detachment or history of retinal detachment
    • Trauma
    • Infectious or inflammatory retinal diseases
  • Diseases or conditions that prevent adequate visualization of the retina including, but not limited to corneal degeneration that cannot be resolved before implant.
  • Diseases or conditions of the anterior segment that prevent the ability to adequately perform the physical examination including but not limited to trauma or lid malpositions.
  • Diseases of the ocular surface including but not limited to keratitis sicca.
  • An ocular condition that predisposes the subject 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 neurological disease
    • Psychiatric Disease including diagnosed forms of depression
    • Does not speak a principal language associated with the region
    • Deafness or selective frequency hearing loss that prevents hearing device alarms and alerts.
  • Pregnancy
  • Subject has another active implantable device (e.g. cochlear implant), or any form of metallic implant in the head
  • Conjunctival thinning which may predispose the subject to conjunctival erosion in the area where the implant will be installed extra-ocularly.
  • Subject is participating in another investigational drug or device study that may conflict with the objectives, follow-up or testing of this study
  • Any health concern that makes general anesthesia inadvisable.
  • Subject has unrealistic expectations of the implant.
  • Known allergy or contraindication to anticipated pre-operative, intra-operative or post-operative medications.
  • Conditions likely to limit life to less than 1 year from the time of screening.
  • Diseases or conditions that, in the judgement of the surgeon, impede the ability to implant the device or would prevent the system from functioning for the duration of the study (e.g. strabismus)
  • Axial eye length <21.5 mm or >26.0 mm in the implanted eye as measured by ultrasound (US only)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Implant of Argus II Retinal Prosthesis
This is a single group study where the status and performance of the implanted eye prior to surgery serves as the comparator.
Device: Implant of Argus II Retinal Prosthesis
epiretinal implantation of device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity
Time Frame: 10 years
Grating Visual Acuity is performed at Baseline and at various timepoints throughout the study. As of the 10 year final testing, the total number of subjects that were able to score on the logMAR scale are indicated below. The device has a scale from 1.6 to 2.9 logMAR. Maximum likelihood estimation of visual acuity is based on BEST-PEST algorithm.
10 years
Number of Participants With Adverse Events
Time Frame: 10 years
Evaluate ocular adverse events reported for all subjects from day of implant through 10 years of study participation
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Massof Activity Inventory
Time Frame: 3 years
The Massof Activity Inventory measures changes in ability to perform activities of daily living in terms of Goals and Tasks in logits (log-odds units). A logit scale is an equal interval linear scale that represents probability values in terms of real numbers. There is no minimum or maximum scale used in this testing. In this case, a Rasch distribution (using an Andrich rating model) was used to find the maximum likelihood of difficulty of achieving Goals and Tasks, represented in logits. The change in mean logit value between baseline and the 36Month visit for each subject are provided below along with the 95% confidence interval (CI) for the change. A positive change in the Goals or Tasks score which is greater than 0.2 (with a CI less than the mean logit value), is interpreted as a clinically significant increase in functional ability (better outcome).
3 years
Quality of Life - Tasks for Daily Living
Time Frame: 3 years
Quality of life is being measured using the VisQOL survey. This instrument, developed by researchers at the University of Melbourne, Australia, is a vision and quality of life-related utility measure intended to evaluate healthcare interventions for the visually impaired. The utility score is a preference-based measure of vision-related quality of life (Dimension 7 score (Health Dimension Score (1=Best, 0=Worst)). It measures subjective quality of life on a scale of 0 to 1, where 0 represents worst possible quality of life and 1 represents perfect quality of life.
3 years
Orientation and Mobility
Time Frame: 5 years
Argus II System for orientation and mobility, each subject completed two tests (walking to a high-contrast "door" on the wall and following a straight line on the floor) at various timepoints throughout the study. Accuracy (percent of trials where the subject successfully reached the target) was measured with the device system ON and system OFF. Average % success rates across the analysis population are provided for each modality and for each test at the 60 month time point.
5 years
Visual Function
Time Frame: 10 years
Square localization (SL) and Direction of Motion (DOM) testing performed at specific protocol intervals. SL tests ability of subjects to locate high-contrast square on black screen. DOM tests ability of subjects to determine the direction a white bar is moving over a black screen. Each test is performed with the system ON and then compared to performance with the system OFF. Number of subjects who performed significantly better with the system ON is indicated below.
10 years
Stability of Implant - 5 Years Post Implant
Time Frame: 5 years
Stability of electrode array on the retina. Qualitative review of imaging: retinal and array landmarks compared from all time points post implant.
5 years
Device Reliability
Time Frame: 10 years
Number of participants with functional devices 10 years post implant
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Sight Medical Products

Collaborators

National Eye Institute (NEI)

Investigators

  • Study Director: Anne-Marie Ripley, Second Sight Medical Products

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

December 1, 2006

First Submitted That Met QC Criteria

December 1, 2006

First Posted (Estimate)

December 5, 2006

Study Record Updates

Last Update Posted (Actual)

January 20, 2022

Last Update Submitted That Met QC Criteria

January 11, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-003-001
  • National Eye Institute (NEI) (Other Grant/Funding Number: 2R01EY012893-06A1)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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