Clinical trial NCT02303288: Post-Market Study of the Argus® II Retinal Prosthesis System - France
Official title: Post-Market Study of the Argus® II Retinal Prosthesis System - France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinitis Pigmentosa
Lead sponsor: Second Sight Medical Products
Sponsor class: INDUSTRY
First posted: 2014-11-27
Enrollment: 18
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: Patients with retinitis pigmentosa who have bare light perception or worse in both eyes

Brief summary: This is a post-market study of the Argus II Retinal Prosthesis System. The study is being conducted in France. The objective of the study is to obtain data to further demonstrate the effectiveness and evaluate the safety of Argus II System in patients with retinitis pigmentosa who have a bare light perception or worse in both eyes.

Detailed description: This study is a controlled, prospective, multi-centre, single-arm post-market study. All data collected will be obtained from procedures that are performed as part of routine patient case and from non-interventional questionnaires.

Control will consist of three different matched comparisons:

* Post vs. pre-implantation (Baseline) data.
* Prospective within-subject comparisons (implanted vs. non implanted eye)
* Prospective subjects' visual performance Argus II System ON vs Argus II System OFF.

Subjects participating in the study will undergo a Baseline Visit. The Baseline Visit is performed to screen the subject for eligibility for the device and to collect the study baseline assessments. Assessments include a complete eye examination and medical evaluation, retinal photography and Optical Coherence Tomography, Ultrasound A- and B-scans, the photographic flash test, visual acuity tests, the FLORA and a psychosocial evaluation in order to ensure that the subject has realistic expectations about the system. The NEI-VFQ-25 questionnaire will also be administered.

Subjects who are enrolled in the study will undergo a surgery to have the Argus II device implanted. Following implantation surgery, subjects will return to the clinic for periodic clinical follow-up and device fitting. They will also receive training and visual rehabilitation.

Clinical follow-up visits will take place 1 and 2 weeks, 1, 3, 6, 12 and 24 months post-implant. Examinations and tests will be performed as at baseline. In addition, a patient satisfaction, Ease of Use, and Utilization of the System Questionnaire will be administered. Most of the visual function tests and measures will be conducted in both the implanted and fellow eye to provide data on the natural course of the participants' vision loss and as a control for measurements of visual function. In addition, the visual function tests and the FLORA will be done for the implanted eye with the device ON as well as OFF.

Device Fitting refers to the procedure for customizing the Video Processing Unit (VPU) for use by the subject. Device Fitting is typically begins one week post-implant and is completed in approximately 4 sessions.

Beginning approximately one month post-implant, subjects will receive training on how to use the Argus II System. There are two phases of training: system training and visual rehabilitation. During system training, subjects learn basic skills: how to connect the glasses to the VPU, change battery etc., how to control eye movements and RF link, how to scan the environment with head movements and how to use different filters and switch between program settings. During visual rehabilitation, subjects learn how to integrate the use of the Argus II System into their everyday life. Visual rehabilitation sessions will be provided by certified low-vision therapists and/or orientation and mobility specialists and will take place both at the clinic and the subject's home.

Eligibility criteria: Inclusion Criteria:

* Are adults, age 25 years or older;
* Have retinitis pigmentosa with visual acuity of bare light perception or worse in both eyes;
* Have previous history of useful form vision;
* If the subject has no residual light perception, the retina must be able to respond to electrical stimulation;
* The subject is willing to provide written, informed consent to participate in the study.

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;
* 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;
* At the time of the Baseline Visit, suffering from non-ophthalmic serious adverse events (e.g. coma, myocardial infarction, etc.).

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;
* 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;
* At the time of the Baseline Visit, suffering from non-ophthalmic serious adverse events (e.g. coma, myocardial infarction, etc.).

Primary outcomes:
measure: Functional Vision - FLORA
timeFrame: 2 Years
measure: Adverse events
timeFrame: 2 Years
Secondary outcomes:
measure: Patient Satisfaction and ease of use of the System
timeFrame: 2 years
measure: Visual Function
timeFrame: 2 years
measure: Functional Vision
timeFrame: 2 years
measure: Explantation rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
city: Paris
country: France
facility: Centre hospitalier National d'Ophtalmologie des Quinze-Vingts
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: CHNO des Quinze-Vingts
name: Pierre-Olivier Barale, MD
role: PRINCIPAL_INVESTIGATOR
References: