Retinitis PigmentosaOX-RINCT02720640
Safety and Efficacy of the Alpha AMS Subretinal Implant
A study testing Implant 'on' vs implant 'off' in people with Retinitis Pigmentosa, run by University of Oxford at 1 site in United Kingdom.
Trial summary
The aim of this single-centre study is to assess the safety and efficacy of the Retina Implant Alpha AMS (Retina Implant AG, Reutlingen, Germany) in participants with severe visual impairment secondary to outer retinal degeneration caused by retinitis pigmentosa (RP). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Retinitis Pigmentosa
- What is being tested?
- Implant 'on' vs implant 'off'
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2015to Oct 2017
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the trial.
- Male or Female, aged 18 to 70 years old.
- Hereditary retinal degeneration of the outer retinal layers i.e. photoreceptor rods \& cones.
- Angiography shows retinal vessels adequately perfused, despite pathological RP condition.
- Severe visual impairment (at least monocular) i.e. visual functions insufficient for localization of objects, self-sustained navigation and orientation e.g. impaired light localization or worse.
- Ability to read normal print in earlier life, optically corrected (without magnifying glass).
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- Able to participate in the study during the full time period of one year.
- Pseudophakic in the eye to receive the implant.
- Stable dose of current regular medication for at least four weeks prior to trial entry.
- Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial.
- Participant has clinically acceptable laboratory and ECG results as confirmed at - Screening Visit and upon review by consultant anaesthetist.
- In the Investigator's opinion, is able and willing to comply with all trial requirements.
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.
Who cannot join
- Period of appropriate visual functions < 12 years / lifetime.
- Optical coherence tomography (OCT) shows significant retina oedema \&/or scar tissue within target region for implant.
- Retina detected as too thin to expect required functionality of inner retina as shown via OCT.
- Lack of inner-retinal function, as determined by Electrically Evoked Phosphenes (EEP).
- Heavy clumped pigmentation at posterior pole.
- Any other ophthalmologic disease with relevant effect upon visual function (e.g. glaucoma, optic neuropathies, trauma, diabetic retinopathy, retinal detachment).
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- Amblyopia reported earlier in life for eye to be implanted.
- Systemic diseases that might imply considerable risks with regard to the surgical interventions and anesthesia (e.g. cardiovascular/ pulmonary diseases, significant metabolic diseases e.g. diabetes).
- Neurological and/or psychiatric diseases (e.g. Parkinson, epilepsy, depression).
- Hyperthyroidism or hypersensitivity to iodine.
- Hypersensitivity to fluorescent dye (fluorescence angiography).
- Women who are pregnant or nursing, or women of childbearing age who are not willing to use a medically acceptable means of birth control for the duration of the study, or women unwilling to perform a pregnancy test before entering the study.
- Participation in another interventional clinical trial within the past 12 weeks.
- Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, OX3 9DU
About this study
Official title: Safety and Efficacy of the Alpha AMS Subretinal Implant for Partial Restoration of Vision in Visually Impaired Participants With Degenerative Retinal Disease
The aim of this single-centre study is to assess the safety and efficacy of the Retina Implant Alpha AMS (Retina Implant AG, Reutlingen, Germany) in participants with severe visual impairment secondary to outer retinal degeneration caused by retinitis pigmentosa (RP). The study is sponsored by the University of Oxford and funded by the National Institute for Health Research (UK).
Read the detailed description
The specific research questions are, i) can the implant partially restore vision to an eye with no light perception and ii) what are the safety implications for the ocular and periorbital tissues of the implanted eye? In advanced RP the light detecting photoreceptor cells of the retina degenerate slowly over time, and may eventually lead to blindness. The subretinal implant replaces the degenerate photoreceptor layer and stimulates the residual overlying healthy retinal layers in response to a light stimulus. These signals are then carried on to the brain along the normal visual pathway. Investigators are seeking to recruit six participants who fulfill the eligibility criteria, which include advanced RP with no useful light perception vision in the eye to receive the implant. Participants must be aged between 18 and 70 years old, be highly motivated, and be well enough for a general anaesthetic. The eye must have also had cataract surgery. The project will be conducted at the Oxford Eye Hospital. Those participants selected to receive the implant will be followed for 12 months from the date of surgery. Between week 1 and month 12 there will be at least 7 outpatient clinic visits for a range of visual tests and eye assessments. After 12 months the trial will officially end, however investigators will continue to review all research participants in clinic as would be standard care for a patient with RP. The implant may be removed at any stage e.g. when it ceases to function or at the participant's request.
- Conditions
- Retinitis Pigmentosa
- Being tested
- Implant 'on' vs implant 'off'
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant 'on' vs implant 'off'Device
Also called Alpha AMS, Retinal Implant Alpha AMS, Retinal implant, Bionic eye
Single group assignment
| Study group | Role | What they receive |
|---|---|---|
| Implant 'on' vs implant 'off' | Experimental | Intra-individual comparison of implant 'on' vs implant 'off' Receives: Device: Implant 'on' vs implant 'off' |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the Alpha AMS retinal implant system used for activities of daily living tasks.
Activities of daily living are assessed with implant ON versus OFF via:
- Activities of daily living tasks
Measured: 12 months
Secondary outcomes (4)
Efficacy of the Alpha AMS retinal implant system used for partial restoration of visual acuity.
Visual acuity or light-perception and/or object-recognition assessed with implant ON versus OFF via
- Freiburg visual Acuity and Contrast Test (FrACT)
Measured: 12 months
Efficacy of the Alpha AMS retinal implant system used for partial restoration of basic light detection..
Visual acuity or light-perception and/or object-recognition assessed with implant ON versus OFF via:
- Basic Light and Motion test (BaLM)
Measured: 12 months
Efficacy of the Alpha AMS retinal implant system used for partial restoration of grating acuity.
Visual acuity or light-perception and/or object-recognition assessed with implant ON versus OFF via:
- Basic Grating Acuity test (BaGA).
Measured: 12 months
Safety of the Alpha AMS retinal implant.
The number of participant with Adverse Events and/or Serious Adverse Events, as defined by the Study Protocol, will be reported.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2016 (estimated)
- Study startMay 2015
- Primary completionOct 2017
- Study completionOct 2017
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 of OxfordThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert E MacLaren, DPhil FRCS, Principal investigator, 1. Nuffield Laboratory of Ophthalmology, Department of Clinical Neurosciences, University of Oxford; 2. Oxford Eye Hospital, Oxford University Hospitals NHS Foundation Trust; 3. Moorfields Eye Hospital NHS Foundation Trust, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720640
- Sponsor's protocol ID
- E/2015/0119
- Acronym
- OX-RI
- Status last verified
- Nov 2017
- First submitted
- 4 Dec 2015
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Cehajic Kapetanovic J, Troelenberg N, Edwards TL, Xue K, Ramsden JD, Stett A, Zrenner E, MacLaren RE. Highest reported visual acuity after electronic retinal implantation. Acta Ophthalmol. 2020 Nov;98(7):736-740. doi: 10.1111/aos.14443. Epub 2020 Apr 28.
PubMed 32343050Stingl K, Schippert R, Bartz-Schmidt KU, Besch D, Cottriall CL, Edwards TL, Gekeler F, Greppmaier U, Kiel K, Koitschev A, Kuhlewein L, MacLaren RE, Ramsden JD, Roider J, Rothermel A, Sachs H, Schroder GS, Tode J, Troelenberg N, Zrenner E. Interim Results of a Multicenter Trial with the New Electronic Subretinal Implant Alpha AMS in 15 Patients Blind from Inherited Retinal Degenerations. Front Neurosci. 2017 Aug 23;11:445. doi: 10.3389/fnins.2017.00445. eCollection 2017.
PubMed 28878616
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Alpha AMS Subretinal Implant for Partial Restoration of Vision in Visually Impaired Participants With Degenerative Retinal Disease
- ClinicalTrials.gov ID
- NCT02720640
- Acronym / sponsor ID
- OX-RI / E/2015/0119
- Conditions
- Retinitis Pigmentosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 28 Mar 2016 (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 aim of this single-centre study is to assess the safety and efficacy of the Retina Implant Alpha AMS (Retina Implant AG, Reutlingen, Germany) in participants with severe visual impairment secondary to outer retinal degeneration caused by retinitis pigmentosa (RP). The study is sponsored by the University of Oxford and funded by the National Institute for Health Research (UK).
Detailed description
The specific research questions are, i) can the implant partially restore vision to an eye with no light perception and ii) what are the safety implications for the ocular and periorbital tissues of the implanted eye? In advanced RP the light detecting photoreceptor cells of the retina degenerate slowly over time, and may eventually lead to blindness. The subretinal implant replaces the degenerate photoreceptor layer and stimulates the residual overlying healthy retinal layers in response to a light stimulus. These signals are then carried on to the brain along the normal visual pathway. Investigators are seeking to recruit six participants who fulfill the eligibility criteria, which include advanced RP with no useful light perception vision in the eye to receive the implant. Participants must be aged between 18 and 70 years old, be highly motivated, and be well enough for a general anaesthetic. The eye must have also had cataract surgery. The project will be conducted at the Oxford Eye Hospital. Those participants selected to receive the implant will be followed for 12 months from the date of surgery. Between week 1 and month 12 there will be at least 7 outpatient clinic visits for a range of visual tests and eye assessments. After 12 months the trial will officially end, however investigators will continue to review all research participants in clinic as would be standard care for a patient with RP. The implant may be removed at any stage e.g. when it ceases to function or at the participant's request.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implant 'on' vs implant 'off' | Experimental | Device: Implant 'on' vs implant 'off'Intra-individual comparison of implant 'on' vs implant 'off' |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Participant is willing and able to give informed consent for participation in the trial.
- Male or Female, aged 18 to 70 years old.
- Hereditary retinal degeneration of the outer retinal layers i.e. photoreceptor rods \& cones.
- Angiography shows retinal vessels adequately perfused, despite pathological RP condition.
- Severe visual impairment (at least monocular) i.e. visual functions insufficient for localization of objects, self-sustained navigation and orientation e.g. impaired light localization or worse.
Key exclusion criteria (15 listed)
- Period of appropriate visual functions < 12 years / lifetime.
- Optical coherence tomography (OCT) shows significant retina oedema \&/or scar tissue within target region for implant.
- Retina detected as too thin to expect required functionality of inner retina as shown via OCT.
- Lack of inner-retinal function, as determined by Electrically Evoked Phosphenes (EEP).
- Heavy clumped pigmentation at posterior pole.
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 |
|---|---|---|
| Implant 'on' vs implant 'off'Also: Alpha AMS, Retinal Implant Alpha AMS, Retinal implant, Bionic eyeSingle group assignment | Device | Implant 'on' vs implant 'off' |
Primary outcome
Efficacy of the Alpha AMS retinal implant system used for activities of daily living tasks.
Time frame: 12 months
Activities of daily living are assessed with implant ON versus OFF via: • Activities of daily living tasks
4 secondary outcomes
Efficacy of the Alpha AMS retinal implant system used for partial restoration of visual acuity.
Time frame: 12 months
Efficacy of the Alpha AMS retinal implant system used for partial restoration of basic light detection..
Time frame: 12 months
Efficacy of the Alpha AMS retinal implant system used for partial restoration of grating acuity.
Time frame: 12 months
Safety of the Alpha AMS retinal implant.
Time frame: 12 months
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 17 Nov 2017.
- Derived from this study: PubMed 32343050Cehajic Kapetanovic J, Troelenberg N, Edwards TL, Xue K, Ramsden JD, Stett A, Zrenner E, MacLaren RE. Highest reported visual acuity after electronic retinal implantation. Acta Ophthalmol. 2020 Nov;98(7):736-740. doi: 10.1111/aos.14443. Epub 2020 Apr 28.
- Derived from this study: PubMed 28878616Stingl K, Schippert R, Bartz-Schmidt KU, Besch D, Cottriall CL, Edwards TL, Gekeler F, Greppmaier U, Kiel K, Koitschev A, Kuhlewein L, MacLaren RE, Ramsden JD, Roider J, Rothermel A, Sachs H, Schroder GS, Tode J, Troelenberg N, Zrenner E. Interim Results of a Multicenter Trial with the New Electronic Subretinal Implant Alpha AMS in 15 Patients Blind from Inherited Retinal Degenerations. Front Neurosci. 2017 Aug 23;11:445. doi: 10.3389/fnins.2017.00445. eCollection 2017.
- Individual participant dataSharing planned: Undecided
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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 E MacLaren, DPhil FRCS principal investigator
1. Nuffield Laboratory of Ophthalmology, Department of Clinical Neurosciences, University of Oxford; 2. Oxford Eye Hospital, Oxford University Hospitals NHS Foundation Trust; 3. Moorfields Eye Hospital NHS Foundation Trust, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant 'on' vs implant 'off' in people with Retinitis Pigmentosa, run by University of Oxford 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 13 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 17 Nov 2017. 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?
Efficacy of the Alpha AMS retinal implant system used for activities of daily living tasks. (time frame: 12 months). 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 NCT02720640, 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 17 Nov 2017.