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Outer Retinal DegenerationNCT01490827

Argus® II Retinal Prosthesis System Post-Market Surveillance Study

An observational study of Outer Retinal Degeneration and Retinitis Pigmentosa, run by Second Sight Medical Products at 10 sites in 2 countries.

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-market surveillance study is conducted in the European Economic Area where Argus II has been CE certified for use in outer retinal degeneration patients. Read more about this study

Who is it for?
Ages 25 years and older
How many people
52 participants
Where
10 sitesin 2 countries
Study dates
Nov 2011to 31 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: Subjects will be selected from eligible patients who have been implanted with the Argus II retinal prosthesis at the enrolling center.

Who may be able to join

  • Adults, age 25 year or older
  • with severe to profound outer retinal degeneration (not including Age-related Macular Degeneration)
  • Have some residual light perception. If no residual light perception remains, the retina must be able to respond to electrical stimulation;
  • Have previous history of useful form vision
  • Have consented to participate in the study
  • Had an Argus II Retinal Prosthesis surgically implanted 14 days (± 7 days) prior to enrollment (at Baseline Visit) in the study
  • At the time of the Baseline Visit, do not suffer from non-ophthalmic serious adverse events (e.g. coma, myocardial infarction, etc.).

Who cannot join

  • Ocular diseases or conditions that could prevent Argus II from working (e.g. optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, severe strabismus, etc.)
  • 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; choroidal neovascularization in the area of the intended tack location, etc.)
  • Ocular diseases or conditions (other than cataracts) that prevent adequate visualization of the inner structures of the eye (e.g. corneal opacity)
  • 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,
Show all 12Show fewer
  • psychiatric disease including diagnosed forms of depression;
  • does not speak a principal language associated with the region, and
  • deafness or selective frequency hearing loss that prevents hearing device alarms and alerts
  • Participants who are pregnant or wish to become pregnant during the course of the study
  • Participation 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

10 sites in 2 countries.

10 sites in 2 countries

Germany8 sites

  • RWTH University Eye Clinic

    Aachen, 52074

  • Center for Ophthalmology - University of Koln

    Cologne, North Rhine-Westphalia, 50924

  • University Hospital Hamburg-Eppendorf, Klinik u. Poliklinik fur Augenheilkunde

    Hamburg, 20246

  • Augenklinik des Staedtischen Klinikums

    Karlsruhe, Baden-Wurttemberg, 76133

  • Universitätsklinikum Leipzig AöR, Klinik und Poliklinik für Augenheilkunde

    Leipzig, 04103

  • University Medical Center Schleswig-Holstein, Department of Ophthalmology

    Lübeck, Schleswig-Holstein, 23538

  • Klinikum rechts der Isar - Technical University

    Munich, Bavaria, 81675

  • Knappschaftsklinikum Saar, Department of Ophthalmology

    Sulzbach, Saarland, 66280

Other trials in Germany

Italy2 sites

  • ULSS 15 Alta Padovana Hospital

    Camposampiero, Veneto, 35012

  • University of Pisa Eye Surgery Department

    Pisa, Tuscany, 56100

Other trials in Italy

About this study

This post-market surveillance study is conducted in the European Economic Area where Argus II has been CE certified for use in outer retinal degeneration patients.

Read the detailed description

This study is being conducted to monitor the use of Argus II in a larger population than available within pre-market approval studies. Safety data will be monitored to ensure continued acceptability of risks to study participants, and an attempt will be made to include all eligible and willing participants implanted with Argus II. Measures of visual function that may contribute to device improvements will also be gathered and evaluated.

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 NCT01490827
Study groupRoleWhat they receive
Argus II Retinal ProsthesisPatients implanted with an Argus II Retinal Prosthesis

What is being measured

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

  1. adverse events

    nature and rate of adverse events

    Measured: up to 3 years from time of implantation

Secondary outcomes (1)

  1. visual function

    Square localization, direction of motion, grating visual acuity

    Measured: up to 3 years from time of implantation

Timeline

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

  1. First posted13 Dec 2011 (estimated)
  2. Study startNov 2011
  3. Primary completion31 Mar 2020
  4. Study completion31 Mar 2020

Why it stopped: Sponsor discontinued the Argus II product

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
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01490827
Sponsor's protocol ID
PM-01
Status last verified
May 2020
First submitted
5 Dec 2011
Last updated
21 May 2020
Results posted
No
Data monitoring committee
No

Publications

  • da Cruz L, Coley BF, Dorn J, Merlini F, Filley E, Christopher P, Chen FK, Wuyyuru V, Sahel J, Stanga P, Humayun M, Greenberg RJ, Dagnelie G; Argus II Study Group. The Argus II epiretinal prosthesis system allows letter and word reading and long-term function in patients with profound vision loss. Br J Ophthalmol. 2013 May;97(5):632-6. doi: 10.1136/bjophthalmol-2012-301525. Epub 2013 Feb 20.

    PubMed 23426738

  • Weiland JD, Faraji B, Greenberg RJ, Humayun MS, Shellock FG. Assessment of MRI issues for the Argus II retinal prosthesis. Magn Reson Imaging. 2012 Apr;30(3):382-9. doi: 10.1016/j.mri.2011.12.005. Epub 2012 Jan 20.

    PubMed 22260934

  • Schaffrath K, Schellhase H, Walter P, Augustin A, Chizzolini M, Kirchhof B, Grisanti S, Wiedemann P, Szurman P, Richard G, Greenberg RJ, Dorn JD, Parmeggiani F, Rizzo S. One-Year Safety and Performance Assessment of the Argus II Retinal Prosthesis: A Postapproval Study. JAMA Ophthalmol. 2019 Aug 1;137(8):896-902. doi: 10.1001/jamaophthalmol.2019.1476.

    PubMed 31145440

  • 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

  • Rizzo S, Belting C, Cinelli L, Allegrini L. Visual field changes following implantation of the Argus II retinal prosthesis. Graefes Arch Clin Exp Ophthalmol. 2015 Feb;253(2):323-5. doi: 10.1007/s00417-014-2822-0. Epub 2014 Nov 30. No abstract available.

    PubMed 25432093

  • Olson JL, Velez-Montoya R, Mandava N, Stoldt CR. Intravitreal silicon-based quantum dots as neuroprotective factors in a model of retinal photoreceptor degeneration. Invest Ophthalmol Vis Sci. 2012 Aug 17;53(9):5713-21. doi: 10.1167/iovs.12-9745.

    PubMed 22761263

Questions about this trial

What is this clinical trial studying?

An observational study of Outer Retinal Degeneration and Retinitis Pigmentosa, run by Second Sight Medical Products at 10 sites in 2 countries.

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 7 inclusion and 12 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 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany, Italy. 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: Sponsor discontinued the Argus II product). 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?

adverse events (time frame: up to 3 years from time of implantation). 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 NCT01490827, which also lists 6 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 21 May 2020.

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