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Retinitis PigmentosaNCT01860092

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

An observational study of Retinitis Pigmentosa, run by Second Sight Medical Products at 17 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 25 years and older
Conditions the study is for
Retinitis Pigmentosa
How many people
53 participants
Where
17 sitesUnited States
Study dates
Jan 2014to Mar 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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;
Show all 14Show fewer
  • 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.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • Retina Consultants of Hawaii

    ‘Aiea, Hawaii, 96701

  • University of Michigan, Kellogg Eye Center

    Ann Arbor, Michigan, 48105

  • Emory University

    Atlanta, Georgia, 30322

  • Johns Hopkins, Lions Vision Center

    Baltimore, Maryland, 21287

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Retina Foundation of the Southwest

    Dallas, Texas, 75231

  • University of Colorado, Denver

    Denver, Colorado, 80204

  • Duke University Eye Center

    Durham, North Carolina, 27710

  • Stony Brook University

    East Setauket, New York, 11733

  • University of Southern California

    Los Angeles, California, 90033

  • U. of Miami, Bascom Palmer Eye Institute

    Miami, Florida, 33136

  • University of Miami Bascom Palmer Eye Institute

    Miami, Florida, 33136

  • University of Minnesota Department of Ophthalmology

    Minneapolis, Minnesota, 55455

  • Wills Eye Hospital / Mid Atlantic Retina

    Philadelphia, Pennsylvania, 19107

  • Mayo Clinic

    Rochester, Minnesota, 55902

Other trials in United States

About this study

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.

Read the 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.

Medical subject headings
Retinitis Pigmentosa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01860092
Study groupRoleWhat they receive
Argus II Retinal ProsthesisPatients implanted with the Argus II Retinal Prosthesis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety subjects have reached 2 years post-implant.

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

    Measured: 5 Years

Secondary outcomes (3)

  1. 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.

    Measured: 5 Years

  2. 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.

    Measured: 5 Years

  3. Device Reliability

    Device reliability will be measured by calculating the rate of implant failure over time.

    Measured: 5 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2013 (estimated)
  2. Study startJan 2014
  3. Primary completionMar 2020
  4. Study completionMar 2020

Why it stopped: Manufacturing ceased for all Argus II and Argus 2s devices (FDA notified of and subsequently approved discontinuation of post approval study in Oct 2021)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01860092
Sponsor's protocol ID
PM-02
Status last verified
Dec 2021
First submitted
14 May 2013
Last updated
23 Dec 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 32131056

  • 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.

    PubMed 29940167

Questions about this trial

What is this clinical trial studying?

An observational study of Retinitis Pigmentosa, run by Second Sight Medical Products at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Manufacturing ceased for all Argus II and Argus 2s devices (FDA notified of and subsequently approved discontinuation of post approval study in Oct 2021)). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety subjects have reached 2 years post-implant. (time frame: 5 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01860092, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2021.

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