Argus® II Retinal Prosthesis System Post-Market Surveillance Study

Retinitis Pigmentosa Clinical Trial

Official title:

Argus® II Retinal Prosthesis System Post-Market Surveillance Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01490827
• Other study ID #: PM-01
• Status: Terminated
• Start date: November 2011
• Est. completion date: March 31, 2020

Study information

• Verified date: May 2020
• Source: Second Sight Medical Products
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Outer Retinal Degeneration
• Retinal Degeneration
• Retinitis
• Retinitis Pigmentosa

Locations

Country	Name	City	State
Germany	RWTH University Eye Clinic	Aachen
Germany	University Hospital Hamburg-Eppendorf, Klinik u. Poliklinik fur Augenheilkunde	Hamburg
Germany	Augenklinik des Staedtischen Klinikums	Karlsruhe	Baden-Wurttemberg
Germany	Center for Ophthalmology - University of Koln	Koln	NRW
Germany	Universitätsklinikum Leipzig AöR, Klinik und Poliklinik für Augenheilkunde	Leipzig
Germany	University Medical Center Schleswig-Holstein, Department of Ophthalmology	Lübeck	Schleswig-Holstein
Germany	Klinikum rechts der Isar - Technical University	Munich	Bavaria
Germany	Knappschaftsklinikum Saar, Department of Ophthalmology	Sulzbach	Saarland
Italy	ULSS 15 Alta Padovana Hospital	Camposampiero	Veneto
Italy	University of Pisa Eye Surgery Department	Pisa	Toscana

Sponsors (1)

Lead Sponsor	Collaborator
Second Sight Medical Products

Countries where clinical trial is conducted

Germany,  Italy, 

References & Publications (3)

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. — View 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 Post — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adverse events	nature and rate of adverse events	up to 3 years from time of implantation
Secondary	visual function	Square localization, direction of motion, grating visual acuity	up to 3 years from time of implantation