Retinitis PigmentosaNCT03418116
Argus II Retinal Prosthesis System - Better Vision RP Study
A study testing Argus II Retinal Prosthesis in people with Retinitis Pigmentosa, run by Second Sight Medical Products at 3 sites in Germany.
Trial summary
The study is conducted to evaluate the safety and benefit of the Argus II System in a selected patient population with advanced Retinitis Pigmentosa who have a measurable central residual visual field smaller than or equal to 5 degrees radius. 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesGermany
- Study dates
- 1 Nov 2018to Nov 2021
- Phase
- Interventional
- 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
Who may be able to join
- Adults, age 25 years or older;
- Diagnosed with advanced Retinitis Pigmentosa (including syndromic RP), Choroideremia, Leber's Congenital Amaurosis, or Rod-Cone disease;
- A measurable central residual visual field of 5° radius or smaller in both eyes, as determined by Goldmann perimetry;
- Visual acuity of 0.1 (1.0 logMAR) or worse in the eye to be implanted, as measured by ETDRS chart;
- Previous history of useful form vision;
- Provided written, informed consent to participate in the study.
Who cannot join
- Ocular diseases or conditions that could prevent the Argus II implant from working (e.g., optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, 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.);
- 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;
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- 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;
- Inability to tolerate general anaesthesia or the recommended antibiotic and steroid regimen associated with the implantation surgery;
- Conditions likely to limit life to less than 1 year from the time of inclusion.
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
RWTH University Eye Clinic
Aachen, 52074
Augenklinik Städtisches Klinikum Karlsruhe
Karlsruhe, Baden-Wurttemberg, 76133
University Medical Center Schleswig-Holstein, Department of Ophthalmology
Lübeck, Schleswig-Holstein, 23538
About this study
The study is conducted to evaluate the safety and benefit of the Argus II System in a selected patient population with advanced Retinitis Pigmentosa who have a measurable central residual visual field smaller than or equal to 5 degrees radius.
Read the detailed description
The Argus II System is intended for use in blind patients with severe to profound retinitis pigmentosa with at least some light perception in the eye to be implanted.
The majority of RP patients still have some central vision even at a very late stage of the disease. This extremely restricted visual field is, however, highly disabling in daily life. The primary objective of this study is to evaluate the safety and benefit of the Argus II System in RP patients characterized as late stage with a central residual visual field smaller than or equal to 5 degrees radius . The electrode array will be placed in a para- to peri foveal location adjacent to the subject's residual visual field, thus increasing the total retinal area receptive to light.
Safety data will be monitored to ensure continued acceptability of risks to study subjects and visual function will be measured to evaluate the effectiveness of the system in this "better vision" RP population. In addition, effects on functional vision and quality of life will be assessed through the Functional Low-Vision Observer Rated Assessment (FLORA) and the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25).
- Conditions
- Retinitis Pigmentosa
- Being tested
- Argus II Retinal Prosthesis
- 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 ProsthesisDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Argus II | Experimental | Implantation of the Argus II Retinal Prosthesis in patients with advanced Retinitis Pigmentosa who have a measurable central residual visual field smaller than or equal to 5 degrees radius. The array will be placed parafoveally, adjacent to the preserved central visual field (i.e., "tunnel vision") in these subjects. Receives: Device: Argus II Retinal Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
The nature and number of adverse events in implanted subjects.
Measured: 2 Years
Visual field
The effect of the Argus II System on visual field size, as measured by Goldmann perimetry
Measured: 2 Years
Secondary outcomes (3)
Visual function
Effect of the Argus II System on visual function, as measured by a suite of visual tests
Measured: 2 Years
Quality of Life
Effect of the Argus II System on quality of life, as measured by the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25)
Measured: 2 Years
Functional vision and quality of life
The general impact of the Argus II on subject's lives, as measured by the Functional Low-Vision Observer Rated Assessment (FLORA)
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 posted1 Feb 2018
- Study start1 Nov 2018 (estimated)
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Why it stopped: Company Decision
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Sight Medical Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Walter, Prof Dr med, Principal investigator, RWTH Aachen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418116
- Sponsor's protocol ID
- CP-08-01
- Status last verified
- Jun 2019
- First submitted
- 25 Jan 2018
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Argus II Retinal Prosthesis System - Better Vision RP Study
- ClinicalTrials.gov ID
- NCT03418116
- Acronym / sponsor ID
- CP-08-01
- Conditions
- Retinitis Pigmentosa
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Second Sight Medical ProductsIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 1 Feb 2018 (actual)
- 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.
The study is conducted to evaluate the safety and benefit of the Argus II System in a selected patient population with advanced Retinitis Pigmentosa who have a measurable central residual visual field smaller than or equal to 5 degrees radius.
Detailed description
The Argus II System is intended for use in blind patients with severe to profound retinitis pigmentosa with at least some light perception in the eye to be implanted.
The majority of RP patients still have some central vision even at a very late stage of the disease. This extremely restricted visual field is, however, highly disabling in daily life. The primary objective of this study is to evaluate the safety and benefit of the Argus II System in RP patients characterized as late stage with a central residual visual field smaller than or equal to 5 degrees radius . The electrode array will be placed in a para- to peri foveal location adjacent to the subject's residual visual field, thus increasing the total retinal area receptive to light.
Safety data will be monitored to ensure continued acceptability of risks to study subjects and visual function will be measured to evaluate the effectiveness of the system in this "better vision" RP population. In addition, effects on functional vision and quality of life will be assessed through the Functional Low-Vision Observer Rated Assessment (FLORA) and the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Argus II | Experimental | Device: Argus II Retinal ProsthesisImplantation of the Argus II Retinal Prosthesis in patients with advanced Retinitis Pigmentosa who have a measurable central residual visual field smaller than or equal to 5 degrees radius. The array will be placed parafoveally, adjacent to the preserved central visual field (i.e., "tunnel vision") in these subjects. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults, age 25 years or older;
- Diagnosed with advanced Retinitis Pigmentosa (including syndromic RP), Choroideremia, Leber's Congenital Amaurosis, or Rod-Cone disease;
- A measurable central residual visual field of 5° radius or smaller in both eyes, as determined by Goldmann perimetry;
- Visual acuity of 0.1 (1.0 logMAR) or worse in the eye to be implanted, as measured by ETDRS chart;
- Previous history of useful form vision;
Key exclusion criteria (12 listed)
- Ocular diseases or conditions that could prevent the Argus II implant from working (e.g., optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, 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.);
- Pre-disposition to eye rubbing;
- Any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols, including:
- Pregnant or wish to become pregnant during the course of the study;
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 ProsthesisThe 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 | Argus II |
Primary outcome
Adverse events
Time frame: 2 Years
The nature and number of adverse events in implanted subjects.
Visual field
Time frame: 2 Years
The effect of the Argus II System on visual field size, as measured by Goldmann perimetry
3 secondary outcomes
Visual function
Time frame: 2 Years
Quality of Life
Time frame: 2 Years
Functional vision and quality of life
Time frame: 2 Years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
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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.
Peter Walter, Prof Dr med principal investigator
RWTH Aachen University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Argus II Retinal Prosthesis in people with Retinitis Pigmentosa, run by Second Sight Medical Products at 3 sites in Germany.
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 6 inclusion and 12 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: withdrawn, as of the sponsor's last update on 25 Jun 2019. 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 Germany. 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 was withdrawn before enrolling participants, so there are no results.
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?
Adverse events (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 25 Jun 2019.