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Argus® II Retinal Prosthesis System Post-Market Surveillance Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Second Sight Medical Products
Sponsor:
Information provided by (Responsible Party):
Second Sight Medical Products
ClinicalTrials.gov Identifier:
NCT01490827
First received: December 5, 2011
Last updated: May 20, 2016
Last verified: May 2016
  Purpose
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. 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.

Condition
Outer Retinal Degeneration
Retinitis Pigmentosa

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Argus® II Retinal Prosthesis System Post-Market Surveillance Study

Resource links provided by NLM:


Further study details as provided by Second Sight Medical Products:

Primary Outcome Measures:
  • nature and rate of adverse events [ Time Frame: up to 3 years from time of implantation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • visual function [ Time Frame: up to 3 years from time of implantation ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: November 2011
Estimated Study Completion Date: May 2021
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients implanted with an Argus II Retinal Prosthesis

  Eligibility

Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be selected from eligible patients who have been implanted with the Argus II retinal prosthesis at the enrolling center.
Criteria

Inclusion Criteria:

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.).

Exclusion Criteria:

  • 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,
    • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01490827

Locations
Germany
Augenklinik des Staedtischen Klinikums Recruiting
Karlsruhe, Baden-Wurttemberg, Germany, 76133
Contact: Jenny Atorf, Dr. rer. nat.    +49-721-974-2034    jenny.atorf@gmail.com   
Principal Investigator: Albert J Augustin, Prof.Dr.med.         
Klinikum rechts der Isar - Technical University Recruiting
Munich, Bavaria, Germany, 81675
Contact: Eva- Maria Stiller, Augenoptik-Meisterin    +49.89.4140.2328    eva.stiller@mri.tum.de   
Principal Investigator: Chris P. Lohmann, Prof.Dr.med.         
Center for Ophthalmology - University of Koln Recruiting
Koln, NRW, Germany, 50924
Contact: Beate Prinz, Dipl.Orthoptistin    +49.221.478.4308    makuladegeneration@uni-koeln.de   
Principal Investigator: Bernd Kirchhof, Prof.Dr.med.         
Knappschaftsklinikum Saar, Department of Ophthalmology Recruiting
Sulzbach, Saarland, Germany, 66280
Contact: Kerstin Bessrich    49 6897-574-3000    k.bessrich@googlemail.com   
Principal Investigator: Peter Szurman, Prof. Dr. med         
University Medical Center Schleswig-Holstein, Department of Ophthalmology Recruiting
Lübeck, Schleswig-Holstein, Germany, 23538
Contact: Nadine Schoenberg    +49 451 500 4399    nadine.schoenberg@uksh.de   
Principal Investigator: Salvatore Grisanti, Prof. Dr. med         
RWTH University Eye Clinic Recruiting
Aachen, Germany, 52074
Contact: Hannah Schimitzek, M.D.    +49-241-8035426    hschimitzek@ukaachen.de   
Contact: Gernot Rössler, M.D.    +49-241-8035460    groessler@ukaachen.de   
Principal Investigator: Peter Walter, Prof. Dr.med.         
University Hospital Hamburg-Eppendorf, Klinik u. Poliklinik fur Augenheilkunde Recruiting
Hamburg, Germany, 20246
Contact: Sonja Barmeyer    +49 40 7410 54417    augenstudien@uke.de   
Principal Investigator: Lars Wagenfeld, Prof. Dr. med.         
Universitätsklinikum Leipzig AöR, Klinik und Poliklinik für Augenheilkunde Recruiting
Leipzig, Germany, 04103
Contact: Maria Tuisl    +49 341 972 16 66    maria.tuisl@medizin.uni-leipzig.de   
Principal Investigator: Peter Wiedemann, Prof. Dr. med.         
Italy
University of Pisa Eye Surgery Department Active, not recruiting
Pisa, Toscana, Italy, 56100
ULSS 15 Alta Padovana Hospital Recruiting
Camposampiero, Veneto, Italy, 35012
Contact: Francesco Parmeggiani, MD PhD    0039 347 4441707    francesco.parmeggiani@unife.it   
Principal Investigator: Marzio Chizzolini, MD         
Sponsors and Collaborators
Second Sight Medical Products
Investigators
Study Director: Anne-Marie Ripley Second Sight Medical Products
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Second Sight Medical Products
ClinicalTrials.gov Identifier: NCT01490827     History of Changes
Other Study ID Numbers: PM-01 
Study First Received: December 5, 2011
Last Updated: May 20, 2016
Health Authority: Germany: Ethics Commission
Italy: Ministry of Health

Additional relevant MeSH terms:
Retinitis Pigmentosa
Retinitis
Retinal Degeneration
Eye Diseases, Hereditary
Eye Diseases
Retinal Dystrophies
Retinal Diseases
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on December 02, 2016