Argus® II Retinal Prosthesis System Post-Market Surveillance Study

NCT ID: NCT01490827

Last Updated: 2020-05-21

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2020-03-31

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.

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.

Conditions

Outer Retinal Degeneration; Retinitis Pigmentosa

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Argus II Retinal Prosthesis

Patients implanted with an Argus II Retinal Prosthesis

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Sight Medical Products

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne-Marie Ripley

Role: STUDY_DIRECTOR

Second Sight Medical Products

Locations

Augenklinik des Staedtischen Klinikums

Karlsruhe, Baden-Wurttemberg, Germany

Klinikum rechts der Isar - Technical University

Munich, Bavaria, Germany

Center for Ophthalmology - University of Koln

Cologne, North Rhine-Westphalia, Germany

Knappschaftsklinikum Saar, Department of Ophthalmology

Sulzbach, Saarland, Germany

University Medical Center Schleswig-Holstein, Department of Ophthalmology

Lübeck, Schleswig-Holstein, Germany

RWTH University Eye Clinic

Aachen, , Germany

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

Hamburg, , Germany

Universitätsklinikum Leipzig AöR, Klinik und Poliklinik für Augenheilkunde

Leipzig, , Germany

University of Pisa Eye Surgery Department

Pisa, Tuscany, Italy

ULSS 15 Alta Padovana Hospital

Camposampiero, Veneto, Italy

Countries

Germany; Italy

References

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.

Reference Type: BACKGROUND

PMID: 23426738 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22260934 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31145440 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29940167 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25432093 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22761263 (View on PubMed)

Other Identifiers

PM-01

Identifier Type: -

Identifier Source: org_study_id