Retinitis PigmentosaNCT02303288
Post-Market Study of the Argus® II Retinal Prosthesis System - France
An observational study of Retinitis Pigmentosa, run by Second Sight Medical Products at 3 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Retinitis Pigmentosa
- What is being tested?
- Argus II Retinal Prosthesis System
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 3 sitesFrance
- Study dates
- 20 Nov 2014to 20 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with retinitis pigmentosa who have bare light perception or worse in both eyes
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 26Show fewer
- 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.).
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, 33000
Centre hospitalier National d'Ophtalmologie des Quinze-Vingts
Paris, 75571
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
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.
Read the 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.
- Conditions
- Retinitis Pigmentosa
- Being tested
- Argus II Retinal Prosthesis System
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Argus II Retinal Prosthesis SystemDevice
The Argus II System is designed to provide visual function to individuals with severe to profound vision loss due to outer retinal degeneration. It consists of implanted and external components. The implant is an epiretinal prosthesis that is surgically implanted in and around the eye. The external equipment includes glasses and a video processing unit (VPU). The glasses include a miniature video camera, which captures video images, and a coil that sends data and stimulation commands to the implant. The VPU converts the video images into stimulation commands and is body-worn. The Argus II System operates by converting video images into electrical energy that activates retinal cells, delivering the signal through the optic nerve to the brain where it is perceived as light.
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Vision - FLORA
The impact of the Argus II on subjects' lives (in terms of functional vision and quality of life) as measured by the Functional Low-vision Observer Rated Assessment (FLORA)
Measured: 2 Years
Adverse events
Incidence of procedure- and device-related adverse events
Measured: 2 Years
Secondary outcomes (4)
Patient Satisfaction and ease of use of the System
A questionnaire will be administered to track how satisfied or dissatisfied subjects are with the Argus II System, how frequently they use the system, how easy or difficult they think the system is to use, and the ways in which they use the System outside the clinic.
Measured: 2 years
Visual Function
Visual function will be assessed using the following tests:
- Square Localization: This test assesses subject's light projection.
- Direction of Motion: This test indicates a subject's ability to detect the direction of a moving object.
- Grating Visual Acuity: This test is designed to determine a subject's visual acuity using the principles of acuity charts such as ETDRS, modified for extremely low vision. It measures visual acuity between 1.6 to 2.9 logMAR.
Subjects' performance on the 3 tests above will be compared:
- Pre-vs. post-implant and. With the Argus II System ON vs. OFF
Measured: 2 years
Functional Vision
The National Eye Institute Visual Function Questionnaire (VFQ-25) will be administered to obtain subjects' self-reported assessment of their vision and what tasks they can perform with their vision (i.e. vision-targeted health status).
Measured: 2 years
Explantation rate
Measure device reliability through explantation rates
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study start20 Nov 2014
- Primary completion20 Mar 2018
- Study completion20 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Sight Medical Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pierre-Olivier Barale, MD, Principal investigator, CHNO des Quinze-Vingts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303288
- Sponsor's protocol ID
- PM-03-01
- Status last verified
- Jun 2020
- First submitted
- 13 Nov 2014
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Study of the Argus® II Retinal Prosthesis System - France
- ClinicalTrials.gov ID
- NCT02303288
- Acronym / sponsor ID
- PM-03-01
- Conditions
- Retinitis Pigmentosa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Second Sight Medical ProductsIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2014 (actual)
- Primary completion
- 20 Mar 2018 (actual)
- Study completion
- 20 Nov 2018 (actual)
- First posted
- 27 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with retinitis pigmentosa who have bare light perception or worse in both eyes
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (26 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Argus II Retinal Prosthesis SystemThe Argus II System is designed to provide visual function to individuals with severe to profound vision loss due to outer retinal degeneration. It consists of implanted and external components. The implant is an epiretinal prosthesis that is surgically implanted in and around the eye. The external equipment includes glasses and a video processing unit (VPU). The glasses include a miniature video camera, which captures video images, and a coil that sends data and stimulation commands to the implant. The VPU converts the video images into stimulation commands and is body-worn. The Argus II System operates by converting video images into electrical energy that activates retinal cells, delivering the signal through the optic nerve to the brain where it is perceived as light. | Device | – |
Primary outcome
Functional Vision - FLORA
Time frame: 2 Years
The impact of the Argus II on subjects' lives (in terms of functional vision and quality of life) as measured by the Functional Low-vision Observer Rated Assessment (FLORA)
Adverse events
Time frame: 2 Years
Incidence of procedure- and device-related adverse events
4 secondary outcomes
Patient Satisfaction and ease of use of the System
Time frame: 2 years
Visual Function
Time frame: 2 years
Functional Vision
Time frame: 2 years
Explantation rate
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Olivier Barale, MD principal investigator
CHNO des Quinze-Vingts
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinitis Pigmentosa, run by Second Sight Medical Products at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Vision - FLORA (time frame: 2 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020.