Age Related Macular DegenerationNCT02227498
Argus II Retinal Prosthesis System Dry AMD Feasibility Study Protocol
A study testing Effect of Argus II on Functional Vision in people with Age Related Macular Degeneration, run by Second Sight Medical Products at 1 site in United Kingdom.
Trial summary
The purpose of this study is to test the Argus II Retinal Prosthesis System in patients with severe age-related macular degeneration (AMD). The Argus II System has already been studied in completely blind patients with retinitis pigmentosa (RP). Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- Effect of Argus II on Functional Vision
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to Mar 2020
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must consent to participate in the study;
- Subject must be between 25 and 85 years of age;
- Subject must be diagnosed with dry AMD (i.e., evidence of drusen and hyperplasia of the RPE in the eye with geographic atrophy secondary to dry AMD);
- Severely sight impaired and meets the following additional criteria:
- Visual acuity of logMAR 1.0 (6/60) or worse in both eyes as measured by ETDRS;
- Hand motion or worse central vision in the eye to be implanted, as measured with a pinhole occluder;
Show all 10Show fewer
- Geographic atrophy (confirmed by Fundus Autofluorescence) and central scotoma (confirmed by microperimetry) in the central 20° or more;
- Subject must be pseudophakic with an IOL successfully implanted in the study eye at least 2 weeks before baseline testing, or aphakic with a clear capsule. If applicable, posterior laser capsulotomy may be performed 2 weeks before baseline testing is performed;
- Subject must be both motivated and competent to learn to use the Argus II System (by the Investigator's assessment), and willing and able to commit to the study requirements. This includes an understanding of the requirements of the study and acceptance of the time involved in participating;
- Subject must not suffer from non-ophthalmic serious adverse events (e.g., myocardial infarction, etc.) or from non-curable life threatening conditions (e.g. cancer) at the time of the Baseline visit.
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.);
- Evidence of active sub-macular choroidal neovascularization (CNV) in implanted eye;
- 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; abnormalities in the typical curvature of the retina like staphyloma and all causes of significant protrusions or depressions in the area centralis that could compromise the optimal position of the electrode array, active or severe blepharitis, etc.);
- Ocular diseases or conditions (other than cataracts) that prevent adequate visualization of the inner structures of the eye (e.g., corneal opacity);
- An Implantable Miniature Telescope in either eye;
- Pre-disposition to eye rubbing;
Show all 15Show fewer
- 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;
- 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
1 site in 1 country.
About this study
The purpose of this study is to test the Argus II Retinal Prosthesis System in patients with severe age-related macular degeneration (AMD). The Argus II System has already been studied in completely blind patients with retinitis pigmentosa (RP). In RP patients, some cells of the retina are irrevocably damaged and the Argus II System has been found to restore some basic visual function. On these grounds, the device has received authorization for use on the European market (the CE certification) in 2011.
Read the detailed description
In this study, 5 subjects with severe dry AMD who are legally blind will be implanted with the Argus II System. The study will evaluate the safety of the device and surgery, as well as functioning of the system and the extent of any restored vision. Each subject will be followed for 3 years, with their eye health and visual function tested at multiple time points.
- Conditions
- Age Related Macular Degeneration
- Being tested
- Effect of Argus II on Functional Vision
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of Argus II on Functional VisionDevice
To evaluate the safety and effectiveness of the Argus II Retinal Prosthesis in subjects with AMD.
| Study group | Role | What they receive |
|---|---|---|
| Effect of Argus II on Functional Vision | Experimental | All subjects enrolled in the study will be implanted with the Argus II Retinal Prosthesis. To evaluate safety and effectiveness of Argus II on visual function. Receives: Device: Effect of Argus II on Functional Vision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
The number of adverse events in implanted subjects.
Measured: Up to 1 year
Visual function
The primary effectiveness endpoint of the study is the effect of the Argus II System on monocular (implanted eye) and binocular visual function, as measured by a suite of visual function tests.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startJun 2015
- Primary completionSep 2019
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular DegenerationStudies 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
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Sight Medical Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jessy Dorn, PhD, Study director, Second Sight Medical Products, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02227498
- Sponsor's protocol ID
- CP-04-01
- Status last verified
- Mar 2020
- First submitted
- 25 Aug 2014
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Argus II Retinal Prosthesis System Dry AMD Feasibility Study Protocol
- ClinicalTrials.gov ID
- NCT02227498
- Acronym / sponsor ID
- CP-04-01
- Conditions
- Age Related Macular Degeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Second Sight Medical ProductsIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Sep 2019 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 28 Aug 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.
The purpose of this study is to test the Argus II Retinal Prosthesis System in patients with severe age-related macular degeneration (AMD). The Argus II System has already been studied in completely blind patients with retinitis pigmentosa (RP). In RP patients, some cells of the retina are irrevocably damaged and the Argus II System has been found to restore some basic visual function. On these grounds, the device has received authorization for use on the European market (the CE certification) in 2011.
Detailed description
In this study, 5 subjects with severe dry AMD who are legally blind will be implanted with the Argus II System. The study will evaluate the safety of the device and surgery, as well as functioning of the system and the extent of any restored vision. Each subject will be followed for 3 years, with their eye health and visual function tested at multiple time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Effect of Argus II on Functional Vision | Experimental | Device: Effect of Argus II on Functional VisionAll subjects enrolled in the study will be implanted with the Argus II Retinal Prosthesis. To evaluate safety and effectiveness of Argus II on visual function. |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject must consent to participate in the study;
- Subject must be between 25 and 85 years of age;
- Subject must be diagnosed with dry AMD (i.e., evidence of drusen and hyperplasia of the RPE in the eye with geographic atrophy secondary to dry AMD);
- Severely sight impaired and meets the following additional criteria:
- Subject must be pseudophakic with an IOL successfully implanted in the study eye at least 2 weeks before baseline testing, or aphakic with a clear capsule. If applicable, posterior laser capsulotomy may be performed 2 weeks before baseline testing is performed;
Key exclusion criteria (15 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.);
- Evidence of active sub-macular choroidal neovascularization (CNV) in implanted eye;
- 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; abnormalities in the typical curvature of the retina like staphyloma and all causes of significant protrusions or depressions in the area centralis that could compromise the optimal position of the electrode array, active or severe blepharitis, etc.);
- Ocular diseases or conditions (other than cataracts) that prevent adequate visualization of the inner structures of the eye (e.g., corneal opacity);
- An Implantable Miniature Telescope in either eye;
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 |
|---|---|---|
| Effect of Argus II on Functional VisionTo evaluate the safety and effectiveness of the Argus II Retinal Prosthesis in subjects with AMD. | Device | Effect of Argus II on Functional Vision |
Primary outcome
Adverse Events
Time frame: Up to 1 year
The number of adverse events in implanted subjects.
Visual function
Time frame: 1 Year
The primary effectiveness endpoint of the study is the effect of the Argus II System on monocular (implanted eye) and binocular visual function, as measured by a suite of visual function tests.
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 18 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Age Related Macular Degeneration
RecruitingPhase 3
Extension Study for the Port Delivery System With Ranibizumab (Portal)
Neovascular Age-Related Macular Degeneration
Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 4
A Study to Determine the Efficacy, Safety, and Durability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration
Neovascular Age-related Macular Degeneration (nAMD)
RecruitingPhase 3
Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
Neovascular Age-related Macular Degeneration
Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy
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.
Jessy Dorn, PhD study director
Second Sight Medical Products, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effect of Argus II on Functional Vision in people with Age Related Macular Degeneration, run by Second Sight Medical Products at 1 site in United Kingdom.
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 10 inclusion and 15 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 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Adverse Events (time frame: Up to 1 year). 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 18 Mar 2020; AzTrials last refreshed its copy on 28 Oct 2026.