Argus® II Retinal Prosthesis System Post-Market Surveillance Study

NCT01490827 | Terminated

• 1 other identifier: PM-01
• Study Type: observational
• Target: 52
• Locations: 2 countries
• Sites: 10

Brief 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.

Conditions

Outer Retinal Degeneration; Retinitis Pigmentosa

Outcome Measures

Primary Outcomes (1)

• adverse events

  nature and rate of adverse events

  up to 3 years from time of implantation

Secondary Outcomes (1)

• visual function

  up to 3 years from time of implantation

Study Arms (1)

Argus II Retinal Prosthesis

Patients implanted with an Argus II Retinal Prosthesis

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.).

You may not qualify if:

• 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;

Sponsors & Collaborators

• Second Sight Medical Products: lead

Study Sites (10)

Augenklinik des Staedtischen Klinikums

Karlsruhe, Baden-Wurttemberg, 76133, Germany

Location

Klinikum rechts der Isar - Technical University

Munich, Bavaria, 81675, Germany

Location

Center for Ophthalmology - University of Koln

Cologne, North Rhine-Westphalia, 50924, Germany

Location

Knappschaftsklinikum Saar, Department of Ophthalmology

Sulzbach, Saarland, 66280, Germany

Location

University Medical Center Schleswig-Holstein, Department of Ophthalmology

Lübeck, Schleswig-Holstein, 23538, Germany

Location

RWTH University Eye Clinic

Aachen, 52074, Germany

Location

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

Hamburg, 20246, Germany

Location

Universitätsklinikum Leipzig AöR, Klinik und Poliklinik für Augenheilkunde

Leipzig, 04103, Germany

Location

University of Pisa Eye Surgery Department

Pisa, Tuscany, 56100, Italy

Location

ULSS 15 Alta Padovana Hospital

Camposampiero, Veneto, 35012, Italy

Location

Related Publications (6)

• 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.

  PMID: 23426738 BACKGROUND

• 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.

  PMID: 22260934 BACKGROUND

• 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.

  PMID: 31145440 RESULT

• 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.

  PMID: 29940167 DERIVED

• 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.

  PMID: 25432093 DERIVED

• 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.

  PMID: 22761263 DERIVED

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Anne-Marie Ripley

  Second Sight Medical Products

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: December 13, 2011
• Study Start: November 1, 2011
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: May 21, 2020

Record last verified: 2020-05

Locations

IT (2); DE (8)