Clinical trial NCT01860092: New Enrollment Post-Approval Study of the Argus® II Retinal Prosthesis System
Official title: New Enrollment Post-Approval Study of the Argus® II Retinal Prosthesis System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Retinitis Pigmentosa
Lead sponsor: Second Sight Medical Products
Sponsor class: INDUSTRY
First posted: 2013-05-22
Enrollment: 53
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: Age 25 years or older; both males and females; with severe to profound retinitis pigmentosa; with bare or no light perception in both eyes or with retinal response to electrical stimulation; with previous history of useful form vision

Brief summary: This post-approval study is being implemented to monitor the use of Argus II System in a larger US population than available within pre-approval studies. An attempt will be made to include all eligible and willing subjects implanted with Argus II System in the United States.

Detailed description: Safety data will be monitored to ensure continued acceptability of risks to study subjects. The utility (i.e. visual function and functional vision) and reliability of Argus II System will also be evaluated.

There is no study hypothesis.

Eligibility criteria: Inclusion Criteria:

* Are adults, age 25 year or older;
* Have severe to profound retinitis pigmentosa;
* Bare light or no light perception in both eyes; if the patient has no residual light perception, then evidence of intact inner layer retina function must be confirmed;
* Have previous history of useful form vision.
* Aphakic or pseudophakic. (If the patient is phakic prior to implant, the natural lens will be removed during the implant procedure.)
* Patients who are willing and able to receive the recommended post-implant clinical follow-up, device fitting, and visual rehabilitation;
* Have consented to the implantation of an Argus II Retinal Prosthesis and subsequently consent to participate in this study;
* At the time of the Baseline Visit, do not suffer from non-ophthalmic serious adverse events (e.g. myocardial infarction, etc.) and

Exclusion Criteria:

* Ocular diseases or conditions that could prevent Argus II System from working (e.g. optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, severe strabismus);
* 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, etc.);
* Ocular diseases or conditions (other than cataracts) that prevent adequate visualization of the inner structures of the eye (e.g. corneal opacity, etc.);
* Inability to tolerate general anesthesia or the recommended antibiotic and steroid regimen associated with the implantation surgery;
* Metallic or active implantable device(s) (e.g. cochlear implant) in the head;
* 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;
* Pregnant or wish to become pregnant during the course of the study;
* Participating 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: Safety subjects have reached 2 years post-implant.
timeFrame: 5 Years
Secondary outcomes:
measure: Visual function
timeFrame: 5 Years
measure: Functional Vision
timeFrame: 5 Years
measure: Device Reliability
timeFrame: 5 Years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Denver
country: United States
facility: University of Colorado, Denver
state: Colorado
city: Miami
country: United States
facility: U. of Miami, Bascom Palmer Eye Institute
state: Florida
city: Miami
country: United States
facility: University of Miami Bascom Palmer Eye Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: 'Aiea
country: United States
facility: Retina Consultants of Hawaii
state: Hawaii
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins, Lions Vision Center
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan, Kellogg Eye Center
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Department of Ophthalmology
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: East Setauket
country: United States
facility: Stony Brook University
state: New York
city: Durham
country: United States
facility: Duke University Eye Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Wills Eye Hospital / Mid Atlantic Retina
state: Pennsylvania
city: Dallas
country: United States
facility: Retina Foundation of the Southwest
state: Texas
Study officials:
affiliation: Second Sight Medical Products, Inc.
name: Jessy Dorn, PhD
role: STUDY_DIRECTOR
References:
citation: Yue L, Wuyyuru V, Gonzalez-Calle A, Dorn JD, Humayun MS. Retina-electrode interface properties and vision restoration by two generations of retinal prostheses in one patient-one in each eye. J Neural Eng. 2020 Apr 9;17(2):026020. doi: 10.1088/1741-2552/ab7c8f.
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.