Retinitis PigmentosaNCT01999049
Observational Study of the Argus® II Retinal Prosthesis System
An observational study of Retinitis Pigmentosa, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The Argus II Retinal Implant is a revolutionary new device, which offers vision to patients who are blind from retinal degeneration - retinitis pigmentosa. These patients have no alternatives. Patients typically can achieve ambulatory vision. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Retinitis Pigmentosa
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2014to Jan 2017
- 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 severe to profound outer retinal degeneration
Who may be able to join
- •Adults, age 25 years or older with severe to profound outer retinal degeneration.
- but some residual light perception. If no residual light perception remains, the retina must be able to respond to electrical stimulation and previous history of useful form vision.
Who cannot join
- Ocular diseases or conditions that could prevent the Argus II System from working (e.g. optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, severe strabismus).
- 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 neovascularisation in the area of the intended tack location, etc.).
- Ocular diseases or conditions (other than cataracts) that prevent adequate visualisation of the inner structures of the eye (e.g. corneal opacity, etc.).
- Inability to tolerate general anaesthesia or the recommended antibiotic and steroid regimen associated with the implantation surgery.
- Predisposition to eye rubbing.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
UHN Toronto Western Hospital 6E-438
Toronto, Ontario, M5t 2S8
Robert Devenyi, MD
About this study
The Argus II Retinal Implant is a revolutionary new device, which offers vision to patients who are blind from retinal degeneration - retinitis pigmentosa. These patients have no alternatives. Patients typically can achieve ambulatory vision.
Read the detailed description
This study is an investigator-sponsored, observational, controlled, prospective, single-center study. The purpose of this current study is how it affects people's visual function and activities of daily living and to collect additional data on Argus II users in order to monitor the System's safety. In addition, data about the long-term reliability of the System will be gathered.
The Argus II retinal implant will be surgical implanted into patients who are blind but the surgical procedure is not a part of this observational study. Our hypothesis is that the visual results in our hands will be comparable to those reported in the FDA study. We will use the results of this study to plan future enhancements to the service and to explore the use of the device for other blinding conditions.
- Conditions
- Retinitis Pigmentosa
- Medical subject headings
- Retinitis Pigmentosa
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
The primary endpoint in the study is safety. Safety will be assessed by calculating the proportion of subjects who experience individual procedure- and device-related adverse events. In addition, the proportion of subjects who experience a significant ocular event will also be reported.
Measured: Patients will be observed for 1 year post-implant.
Secondary outcomes (1)
Visual function
- Visual function: Visual function means how the eye works (e.g. visual acuity). Visual function will be measured using the following tests: Square Localization; Direction of Motion; Grating Visual Acuity (GVA).
- Functional vision: Functional vision means how subjects perform in vision-related activities of daily living. Function vision will be assessed using the Functional Low-Vision Observer Rated Assessment (FLORA). A utilization questionnaire will also be administered to track how subjects are using the Argus II System.
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 posted3 Dec 2013 (estimated)
- Study startApr 2014
- Primary completionJan 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation Fighting Blindness
- Responsible party
- Sponsor
- Investigators
- Robert Devenyi, MD, Principal investigator, University Health Network- Toronto Western Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01999049
- Sponsor's protocol ID
- 50813
- Status last verified
- Apr 2015
- First submitted
- 25 Nov 2013
- Last updated
- 24 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Humayun MS, Dorn JD, da Cruz L, Dagnelie G, Sahel JA, Stanga PE, Cideciyan AV, Duncan JL, Eliott D, Filley E, Ho AC, Santos A, Safran AB, Arditi A, Del Priore LV, Greenberg RJ; Argus II Study Group. Interim results from the international trial of Second Sight's visual prosthesis. Ophthalmology. 2012 Apr;119(4):779-88. doi: 10.1016/j.ophtha.2011.09.028. Epub 2012 Jan 11.
PubMed 22244176Ahuja AK, Yeoh J, Dorn JD, Caspi A, Wuyyuru V, McMahon MJ, Humayun MS, Greenberg RJ, Dacruz L. Factors Affecting Perceptual Threshold in Argus II Retinal Prosthesis Subjects. Transl Vis Sci Technol. 2013 Apr;2(4):1. doi: 10.1167/tvst.2.4.1. Epub 2013 Apr 12.
PubMed 24049718
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of the Argus® II Retinal Prosthesis System
- ClinicalTrials.gov ID
- NCT01999049
- Acronym / sponsor ID
- 50813
- Conditions
- Retinitis Pigmentosa
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Foundation Fighting Blindness
- Study start
- Apr 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 3 Dec 2013 (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 Argus II Retinal Implant is a revolutionary new device, which offers vision to patients who are blind from retinal degeneration - retinitis pigmentosa. These patients have no alternatives. Patients typically can achieve ambulatory vision.
Detailed description
This study is an investigator-sponsored, observational, controlled, prospective, single-center study. The purpose of this current study is how it affects people's visual function and activities of daily living and to collect additional data on Argus II users in order to monitor the System's safety. In addition, data about the long-term reliability of the System will be gathered.
The Argus II retinal implant will be surgical implanted into patients who are blind but the surgical procedure is not a part of this observational study. Our hypothesis is that the visual results in our hands will be comparable to those reported in the FDA study. We will use the results of this study to plan future enhancements to the service and to explore the use of the device for other blinding conditions.
Study design
- Observational model
- Case only
- 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 severe to profound outer retinal degeneration
Key inclusion criteria (2 listed)
- •Adults, age 25 years or older with severe to profound outer retinal degeneration.
- but some residual light perception. If no residual light perception remains, the retina must be able to respond to electrical stimulation and previous history of useful form vision.
Key exclusion criteria (5 listed)
- Ocular diseases or conditions that could prevent the Argus II System from working (e.g. optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, severe strabismus).
- 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 neovascularisation in the area of the intended tack location, etc.).
- Ocular diseases or conditions (other than cataracts) that prevent adequate visualisation of the inner structures of the eye (e.g. corneal opacity, etc.).
- Inability to tolerate general anaesthesia or the recommended antibiotic and steroid regimen associated with the implantation surgery.
- Predisposition to eye rubbing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety
Time frame: Patients will be observed for 1 year post-implant.
The primary endpoint in the study is safety. Safety will be assessed by calculating the proportion of subjects who experience individual procedure- and device-related adverse events. In addition, the proportion of subjects who experience a significant ocular event will also be reported.
1 secondary outcome
Visual function
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
- Background: PubMed 22244176Humayun MS, Dorn JD, da Cruz L, Dagnelie G, Sahel JA, Stanga PE, Cideciyan AV, Duncan JL, Eliott D, Filley E, Ho AC, Santos A, Safran AB, Arditi A, Del Priore LV, Greenberg RJ; Argus II Study Group. Interim results from the international trial of Second Sight's visual prosthesis. Ophthalmology. 2012 Apr;119(4):779-88. doi: 10.1016/j.ophtha.2011.09.028. Epub 2012 Jan 11.
- Background: PubMed 24049718Ahuja AK, Yeoh J, Dorn JD, Caspi A, Wuyyuru V, McMahon MJ, Humayun MS, Greenberg RJ, Dacruz L. Factors Affecting Perceptual Threshold in Argus II Retinal Prosthesis Subjects. Transl Vis Sci Technol. 2013 Apr;2(4):1. doi: 10.1167/tvst.2.4.1. Epub 2013 Apr 12.
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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.
Robert Devenyi, MD principal investigator
University Health Network- Toronto Western Hospital
1 site 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 University Health Network, Toronto at 1 site in Canada.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 24 Apr 2015. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Devenyi, MD (416-603-5602, rdevenyi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: Patients will be observed for 1 year post-implant.). 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 NCT01999049, which also lists 2 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 24 Apr 2015.