Retinitis Pigmentosa(A16)NCT00279500
Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa
A study testing Argus 16 Retinal Stimulation System in people with Retinitis Pigmentosa, run by Second Sight Medical Products at 1 site in United States.
Trial summary
The objective of this study is to evaluate the safety and efficacy of the retinal stimulation system by evaluating the data after chronic implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinitis Pigmentosa
- What is being tested?
- Argus 16 Retinal Stimulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2002to 31 Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed history of retinal degenerative disease in the worse seeing eye with remaining vision no better than light perception. The fellow eye can have any visual acuity but must have better vision than the eye that will have the surgery.
- History of former useful form vision in worse-seeing eye
- Acceptable ability to describe visual percepts
- Age eighteen (18) or older
Who cannot join
- History of glaucoma
- Optic neuropathy or other confirmed damage to optic nerve or visual cortical damage
- Presence of communicable disease/infection
- Pregnancy
- History of claustrophobia
- Inconsistent flash detection thresholds
Show all 9Show fewer
- Any other diseases that can effect the function of the retina
- Subjects with a Beck Depression Inventory Interpretation score of >30 and subsequent diagnosis of depression by a psychiatrist.
- Corneal degeneration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Retinal Electrodes to Provide Electrical Stimulation of the Retina to Elicit Visual Percepts in Blind Subjects
The objective of this study is to evaluate the safety and efficacy of the retinal stimulation system by evaluating the data after chronic implantation.
Read the detailed description
The chronic retinal stimulation system is an implantable electronic device designed to provide electrical stimulation of the retina in order to elicit visual percepts in blind subjects.
This chronic feasibility study will evaluate the ability of subjects to resolve multiple percepts and patterns under various stimulus conditions and optimize the effectiveness of electrical stimulus parameters with an initial chronic design.
- Conditions
- Retinitis Pigmentosa
- Being tested
- Argus 16 Retinal Stimulation 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 16 Retinal Stimulation SystemDevice
The chronic retinal stimulation system is an implantable electronic device designed to provide electrical stimulation of the retina in order to elicit visual percepts in blind subjects.
| Study group | Role | What they receive |
|---|---|---|
| single arm study | Experimental | Argus 16 Retinal Stimulation System-single arm study. Receives: Device: Argus 16 Retinal Stimulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events From 2 Weeks Post-op Until the End of the Study
All adverse events are collected as a result of chronic electrical stimulation and/or surgical complications.
Measured: From 2 weeks post-op until end of device usage, up to 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2006 (estimated)
- Study start27 Feb 2002
- Primary completion31 Dec 2014
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- 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
- Model description
- Subjects with a confirmed history of advanced retinal degenerative disease and meeting the inclusion criteria listed will be considered as eligible participants in the study. Subjects who have a condition listed in the exclusion criteria will not be allowed to participate in the study. Eligible subjects with the above diagnoses will be recruited from the Doheny Eye Institute at the University of Southern California. Additionally, new subjects encountered in the clinic who fulfill the inclusion criteria will also be eligible to participate. Upon meeting the entry criteria, all subjects must sign an Informed Consent prior to enrollment in the study. Since the subjects are blind, an individual not associated with this study must read the informed consent to the subject. This person must sign the consent form as a witness to the informed consent process.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Sight Medical Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Olmos, MD, Principal investigator, Doheny Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279500
- Sponsor's protocol ID
- CP0002
- Acronym
- (A16)
- Status last verified
- Apr 2018
- First submitted
- 17 Jan 2006
- Last updated
- 12 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 32131056Nanduri D, Fine I, Horsager A, Boynton GM, Humayun MS, Greenberg RJ, Weiland JD. Frequency and amplitude modulation have different effects on the percepts elicited by retinal stimulation. Invest Ophthalmol Vis Sci. 2012 Jan 20;53(1):205-14. doi: 10.1167/iovs.11-8401.
PubMed 22110084Eng JG, Agrawal RN, Tozer KR, Ross-Cisneros FN, Dagnelie G, Greenberg RJ, Chader GJ, Weiland JD, Rao NA, Sadun AA, Humayun MS. Morphometric analysis of optic nerves and retina from an end-stage retinitis pigmentosa patient with an implanted active epiretinal array. Invest Ophthalmol Vis Sci. 2011 Jun 28;52(7):4610-6. doi: 10.1167/iovs.09-4936.
PubMed 21296811Horsager A, Boynton GM, Greenberg RJ, Fine I. Temporal interactions during paired-electrode stimulation in two retinal prosthesis subjects. Invest Ophthalmol Vis Sci. 2011 Feb 1;52(1):549-57. doi: 10.1167/iovs.10-5282. Print 2011 Jan.
PubMed 20720224Greenwald SH, Horsager A, Humayun MS, Greenberg RJ, McMahon MJ, Fine I. Brightness as a function of current amplitude in human retinal electrical stimulation. Invest Ophthalmol Vis Sci. 2009 Nov;50(11):5017-25. doi: 10.1167/iovs.08-2897. Epub 2009 Jul 15.
PubMed 19608533Caspi A, Dorn JD, McClure KH, Humayun MS, Greenberg RJ, McMahon MJ. Feasibility study of a retinal prosthesis: spatial vision with a 16-electrode implant. Arch Ophthalmol. 2009 Apr;127(4):398-401. doi: 10.1001/archophthalmol.2009.20.
PubMed 19365014Horsager A, Greenwald SH, Weiland JD, Humayun MS, Greenberg RJ, McMahon MJ, Boynton GM, Fine I. Predicting visual sensitivity in retinal prosthesis patients. Invest Ophthalmol Vis Sci. 2009 Apr;50(4):1483-91. doi: 10.1167/iovs.08-2595. Epub 2008 Dec 20.
PubMed 19098313de Balthasar C, Patel S, Roy A, Freda R, Greenwald S, Horsager A, Mahadevappa M, Yanai D, McMahon MJ, Humayun MS, Greenberg RJ, Weiland JD, Fine I. Factors affecting perceptual thresholds in epiretinal prostheses. Invest Ophthalmol Vis Sci. 2008 Jun;49(6):2303-14. doi: 10.1167/iovs.07-0696.
PubMed 18515576
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Retinal Electrodes to Provide Electrical Stimulation of the Retina to Elicit Visual Percepts in Blind Subjects
- ClinicalTrials.gov ID
- NCT00279500
- Acronym / sponsor ID
- (A16) / CP0002
- Conditions
- Retinitis Pigmentosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Second Sight Medical ProductsIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2002 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 19 Jan 2006 (estimated)
- Results
- Posted 17 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the safety and efficacy of the retinal stimulation system by evaluating the data after chronic implantation.
Detailed description
The chronic retinal stimulation system is an implantable electronic device designed to provide electrical stimulation of the retina in order to elicit visual percepts in blind subjects.
This chronic feasibility study will evaluate the ability of subjects to resolve multiple percepts and patterns under various stimulus conditions and optimize the effectiveness of electrical stimulus parameters with an initial chronic design.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects with a confirmed history of advanced retinal degenerative disease and meeting the inclusion criteria listed will be considered as eligible participants in the study. Subjects who have a condition listed in the exclusion criteria will not be allowed to participate in the study. Eligible subjects with the above diagnoses will be recruited from the Doheny Eye Institute at the University of Southern California. Additionally, new subjects encountered in the clinic who fulfill the inclusion criteria will also be eligible to participate. Upon meeting the entry criteria, all subjects must sign an Informed Consent prior to enrollment in the study. Since the subjects are blind, an individual not associated with this study must read the informed consent to the subject. This person must sign the consent form as a witness to the informed consent process.
| Arm | Type | Receives |
|---|---|---|
| single arm study | Experimental | Device: Argus 16 Retinal Stimulation SystemArgus 16 Retinal Stimulation System-single arm study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed history of retinal degenerative disease in the worse seeing eye with remaining vision no better than light perception. The fellow eye can have any visual acuity but must have better vision than the eye that will have the surgery.
- History of former useful form vision in worse-seeing eye
- Acceptable ability to describe visual percepts
- Age eighteen (18) or older
Key exclusion criteria (9 listed)
- History of glaucoma
- Optic neuropathy or other confirmed damage to optic nerve or visual cortical damage
- Presence of communicable disease/infection
- Pregnancy
- History of claustrophobia
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 16 Retinal Stimulation SystemThe chronic retinal stimulation system is an implantable electronic device designed to provide electrical stimulation of the retina in order to elicit visual percepts in blind subjects. | Device | single arm study |
Primary outcome
Number of Adverse Events From 2 Weeks Post-op Until the End of the Study
Time frame: From 2 weeks post-op until end of device usage, up to 10 years.
All adverse events are collected as a result of chronic electrical stimulation and/or surgical complications.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32131056Yue 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.
- Derived from this study: PubMed 22110084Nanduri D, Fine I, Horsager A, Boynton GM, Humayun MS, Greenberg RJ, Weiland JD. Frequency and amplitude modulation have different effects on the percepts elicited by retinal stimulation. Invest Ophthalmol Vis Sci. 2012 Jan 20;53(1):205-14. doi: 10.1167/iovs.11-8401.
- Derived from this study: PubMed 21296811Eng JG, Agrawal RN, Tozer KR, Ross-Cisneros FN, Dagnelie G, Greenberg RJ, Chader GJ, Weiland JD, Rao NA, Sadun AA, Humayun MS. Morphometric analysis of optic nerves and retina from an end-stage retinitis pigmentosa patient with an implanted active epiretinal array. Invest Ophthalmol Vis Sci. 2011 Jun 28;52(7):4610-6. doi: 10.1167/iovs.09-4936.
- Derived from this study: PubMed 20720224Horsager A, Boynton GM, Greenberg RJ, Fine I. Temporal interactions during paired-electrode stimulation in two retinal prosthesis subjects. Invest Ophthalmol Vis Sci. 2011 Feb 1;52(1):549-57. doi: 10.1167/iovs.10-5282. Print 2011 Jan.
- Derived from this study: PubMed 19608533Greenwald SH, Horsager A, Humayun MS, Greenberg RJ, McMahon MJ, Fine I. Brightness as a function of current amplitude in human retinal electrical stimulation. Invest Ophthalmol Vis Sci. 2009 Nov;50(11):5017-25. doi: 10.1167/iovs.08-2897. Epub 2009 Jul 15.
- Derived from this study: PubMed 19365014Caspi A, Dorn JD, McClure KH, Humayun MS, Greenberg RJ, McMahon MJ. Feasibility study of a retinal prosthesis: spatial vision with a 16-electrode implant. Arch Ophthalmol. 2009 Apr;127(4):398-401. doi: 10.1001/archophthalmol.2009.20.
- Derived from this study: PubMed 19098313Horsager A, Greenwald SH, Weiland JD, Humayun MS, Greenberg RJ, McMahon MJ, Boynton GM, Fine I. Predicting visual sensitivity in retinal prosthesis patients. Invest Ophthalmol Vis Sci. 2009 Apr;50(4):1483-91. doi: 10.1167/iovs.08-2595. Epub 2008 Dec 20.
- Derived from this study: PubMed 18515576de Balthasar C, Patel S, Roy A, Freda R, Greenwald S, Horsager A, Mahadevappa M, Yanai D, McMahon MJ, Humayun MS, Greenberg RJ, Weiland JD, Fine I. Factors affecting perceptual thresholds in epiretinal prostheses. Invest Ophthalmol Vis Sci. 2008 Jun;49(6):2303-14. doi: 10.1167/iovs.07-0696.
- Individual participant dataSharing planned: No
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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.
Lisa Olmos, MD principal investigator
Doheny Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Argus 16 Retinal Stimulation System in people with Retinitis Pigmentosa, run by Second Sight Medical Products at 1 site in United States.
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 4 inclusion and 9 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 12 Apr 2023. 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 States. 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?
Yes. Results are posted in the registry (first posted 17 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Adverse Events From 2 Weeks Post-op Until the End of the Study (time frame: From 2 weeks post-op until end of device usage, up to 10 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00279500, which also lists 8 linked publications.
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 12 Apr 2023.