Clinical trial NCT01490827: Argus® II Retinal Prosthesis System Post-Market Surveillance Study
Official title: Argus® II Retinal Prosthesis System Post-Market Surveillance Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Outer Retinal Degeneration
Retinitis Pigmentosa
Lead sponsor: Second Sight Medical Products
Sponsor class: INDUSTRY
First posted: 2011-12-13
Enrollment: 52
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: adverse events
timeFrame: up to 3 years from time of implantation
Secondary outcomes:
measure: visual function
timeFrame: up to 3 years from time of implantation
Other outcomes:
Locations:
city: Karlsruhe
country: Germany
facility: Augenklinik des Staedtischen Klinikums
state: Baden-Wurttemberg
city: Munich
country: Germany
facility: Klinikum rechts der Isar - Technical University
state: Bavaria
city: Koln
country: Germany
facility: Center for Ophthalmology - University of Koln
state: NRW
city: Sulzbach
country: Germany
facility: Knappschaftsklinikum Saar, Department of Ophthalmology
state: Saarland
city: Lübeck
country: Germany
facility: University Medical Center Schleswig-Holstein, Department of Ophthalmology
state: Schleswig-Holstein
city: Aachen
country: Germany
facility: RWTH University Eye Clinic
city: Hamburg
country: Germany
facility: University Hospital Hamburg-Eppendorf, Klinik u. Poliklinik fur Augenheilkunde
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig AöR, Klinik und Poliklinik für Augenheilkunde
city: Pisa
country: Italy
facility: University of Pisa Eye Surgery Department
state: Toscana
city: Camposampiero
country: Italy
facility: ULSS 15 Alta Padovana Hospital
state: Veneto
Study officials:
affiliation: Second Sight Medical Products
name: Anne-Marie Ripley
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.