Retinal DegenerationNCT03561922
Impact on Daily Life of Patients Using the Subretinal Implant RETINA IMPLANT Alpha AMS
A study testing RETINA IMPLANT Alpha AMS in people with Retinal Degeneration and Inherited Retinal Dystrophy Primarily Involving Sensory Retina, run by Retina Implant AG at 2 sites in France.
Trial summary
This study aims to assess the impact of the subretinal implant RETINA IMPLANT Alpha AMS on the patient's daily life, using validated activities of daily living and questionnaires. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Retinal Degeneration, Inherited Retinal Dystrophy Primarily Involving Sensory Retina
- What is being tested?
- RETINA IMPLANT Alpha AMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesFrance
- Study dates
- 4 Sep 2018to 5 Apr 2019
- 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 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 78
- Willing and able to give written informed consent
- Hereditary retinal degeneration of the outer retinal layer i.e. photoreceptors (rods \& cones)
- Pseudophakia or aphakia in the eye to be implanted
- Retinal vessels with remaining perfusion, despite pathological condition
- Layering of inner retina in the central region present, as shown by Optical Coherence Tomography (OCT)
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- Thickness of the retina sufficient for subretinal surgery as shown by OCT
- Inner retina still functional (proven e.g. by light perception or electrically evoked phosphenes (EEP))
- Blindness in both eyes, (no light perception or light perception only)
- Visual acuity sufficient for reading normal print in earlier life, optically corrected
- Period of appropriate visual functions at least 12 years / lifetime
- Willing and able to perform study assessments and training during the full time period of 12 months
- Motivation to get the best possible results through training and realistic expectations about these as assessed in screening interview
Who cannot join
- OCT shows significant retina edema and/or scar tissue within target region for implant
- Heavy clumped pigmentation at posterior pole or on the planned route of the implantation
- atrophy of optic nerve or ganglion cells degeneration
- Any other ophthalmologic disease with relevant effect upon visual function (e.g. glaucoma, optic neuropathies, trauma, diabetic retinopathy, retinal detachment)
- Deep amblyopia reported earlier in life on eye to be implanted
- Systemic conditions that might imply considerable risks with regard to the surgical interventions and anesthesia (e.g. cardiovascular/pulmonary diseases, severe metabolic diseases)
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- Acute and severe neurological and/or psychiatric diseases
- Hyperthyroidism or hypersensitivity to iodine
- Hypersensitivity to fluorescent dye
- Women who are pregnant or nursing, or women of childbearing potential 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 study within the past 30 days
Trial locations and contacts
2 sites in 1 country.
France2 sites
Clinique Saint Jean
Montpellier, Hérault, 34093
Centre Hospitalier Universitaire La Milétrie de Poitiers
Poitiers, Vienne, 86021
About this study
This study aims to assess the impact of the subretinal implant RETINA IMPLANT Alpha AMS on the patient's daily life, using validated activities of daily living and questionnaires.
Read the detailed description
This study aims to assess the impact of the subretinal implant RETINA IMPLANT Alpha AMS on the patient's daily life. In addition, the study will provide additional information about the safety and efficacy of the CE-certified RETINA IMPLANT Alpha AMS. In several studies it has been shown that patients who received this subretinal implant regain visual function to a certain extent and that its use is safe. So far, all assessments of patients with the RETINA IMPLANT Alpha AMS have been done in a controlled environment within the scope of interventional studies where the benefit in daily life has been assessed anecdotally only. Currently, there is no standard method available for an objective assessment of the impact of such devices in daily life of these patients. Hence, the aim of this study is to further assess the impact in daily life with a combination of already validated and newly developed assessments and questionnaires.
This study adheres to the tenets of the Declaration of Helsinki.
- Being tested
- RETINA IMPLANT Alpha AMS
- Keywords
- Retinal Degeneration, Artificial Vision, Retinal Prosthesis, Subretinal Implant, Inherited Retinal Dystrophy, Vision Restoration, Bionic Eye, Bionic Vision, Retinitis Pigmentosa, Artificial Retina, Retina Implant, Cone-Rod Dystrophy, Choroideremia, Retinopathia Pigmentosa
- Medical subject headings
- Retinal Degeneration, Retinitis Pigmentosa, Cone-Rod Dystrophies, Choroideremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RETINA IMPLANT Alpha AMSDevice
Implantation of the subretinal RETINA IMPLANT Alpha AMS
| Study group | Role | What they receive |
|---|---|---|
| RETINA IMPLANT Alpha AMS | Experimental | All participants receive the subretinal device RETINA IMPLANT Alpha AMS Receives: Device: RETINA IMPLANT Alpha AMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in functional vision
Instrumental Activities of Daily Living assessed at baseline (prior to implantation) versus one year after implantation
Measured: baseline vs. 12 months after implantation
Secondary outcomes (4)
Vision Related Quality of Life - Questionnaire
A validated patient reported outcome questionnaire, IVI-VLV, assessed at baseline versus one year after implantation
Measured: at baseline and 1, 2.5, 4, 6, 9 and 12 months after implantation (and for longterm review after 18 and 24 months)
Visual Function - Questionnaire
A validated patient reported outcome questionnaire, ULV-VFQ, assessed at baseline versus one year after implantation
Measured: at baseline and 1, 2.5, 4, 6, 9 and 12 months after implantation (and for longterm review after 18 and 24 months)
Adverse Events
Number, nature and severity of device-related and implantation-related adverse events
Measured: 2 years
Measure of implant-mediated visual function
Computer test assessed with implant on versus off
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 posted19 Jun 2018
- Study start4 Sep 2018
- Primary completion5 Apr 2019
- Study completion5 Apr 2019
Why it stopped: Manufacturer of the investigational device has ceased all business activities
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 Retinal 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Retina Implant AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicolas Leveziel, Prof, Study chair, Centre Hospitalier Universitaire (CHU) de Poitiers, FrancePierre-André Duval, Dr, Principal investigator, Clinique Saint Jean, Montpellier, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561922
- Sponsor's protocol ID
- RI-FI-2017
- Status last verified
- Apr 2019
- First submitted
- 17 May 2018
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If data are shared, this will only be done in a pseudonymized manner.
Publications
Stingl 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 28878616Edwards TL, Cottriall CL, Xue K, Simunovic MP, Ramsden JD, Zrenner E, MacLaren RE. Assessment of the Electronic Retinal Implant Alpha AMS in Restoring Vision to Blind Patients with End-Stage Retinitis Pigmentosa. Ophthalmology. 2018 Mar;125(3):432-443. doi: 10.1016/j.ophtha.2017.09.019. Epub 2017 Oct 27.
PubMed 29110946
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Daily Life of Patients Using the Subretinal Implant RETINA IMPLANT Alpha AMS
- ClinicalTrials.gov ID
- NCT03561922
- Acronym / sponsor ID
- RI-FI-2017
- Keywords
- Retinal Degeneration, Artificial Vision, Retinal Prosthesis, Subretinal Implant, Inherited Retinal Dystrophy, Vision Restoration, Bionic Eye, Bionic Vision
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Manufacturer of the investigational device has ceased all business activities
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Retina Implant AGIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 5 Apr 2019 (actual)
- Study completion
- 5 Apr 2019 (actual)
- First posted
- 19 Jun 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.
This study aims to assess the impact of the subretinal implant RETINA IMPLANT Alpha AMS on the patient's daily life, using validated activities of daily living and questionnaires.
Detailed description
This study aims to assess the impact of the subretinal implant RETINA IMPLANT Alpha AMS on the patient's daily life. In addition, the study will provide additional information about the safety and efficacy of the CE-certified RETINA IMPLANT Alpha AMS. In several studies it has been shown that patients who received this subretinal implant regain visual function to a certain extent and that its use is safe. So far, all assessments of patients with the RETINA IMPLANT Alpha AMS have been done in a controlled environment within the scope of interventional studies where the benefit in daily life has been assessed anecdotally only. Currently, there is no standard method available for an objective assessment of the impact of such devices in daily life of these patients. Hence, the aim of this study is to further assess the impact in daily life with a combination of already validated and newly developed assessments and questionnaires.
This study adheres to the tenets of the Declaration of Helsinki.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RETINA IMPLANT Alpha AMS | Experimental | Device: RETINA IMPLANT Alpha AMSAll participants receive the subretinal device RETINA IMPLANT Alpha AMS |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18 to 78
- Willing and able to give written informed consent
- Hereditary retinal degeneration of the outer retinal layer i.e. photoreceptors (rods \& cones)
- Pseudophakia or aphakia in the eye to be implanted
- Retinal vessels with remaining perfusion, despite pathological condition
Key exclusion criteria (11 listed)
- OCT shows significant retina edema and/or scar tissue within target region for implant
- Heavy clumped pigmentation at posterior pole or on the planned route of the implantation
- atrophy of optic nerve or ganglion cells degeneration
- Any other ophthalmologic disease with relevant effect upon visual function (e.g. glaucoma, optic neuropathies, trauma, diabetic retinopathy, retinal detachment)
- Deep amblyopia reported earlier in life on eye to be implanted
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 |
|---|---|---|
| RETINA IMPLANT Alpha AMSImplantation of the subretinal RETINA IMPLANT Alpha AMS | Device | RETINA IMPLANT Alpha AMS |
Primary outcome
Change in functional vision
Time frame: baseline vs. 12 months after implantation
Instrumental Activities of Daily Living assessed at baseline (prior to implantation) versus one year after implantation
4 secondary outcomes
Vision Related Quality of Life - Questionnaire
Time frame: at baseline and 1, 2.5, 4, 6, 9 and 12 months after implantation (and for longterm review after 18 and 24 months)
Visual Function - Questionnaire
Time frame: at baseline and 1, 2.5, 4, 6, 9 and 12 months after implantation (and for longterm review after 18 and 24 months)
Adverse Events
Time frame: 2 years
Measure of implant-mediated visual function
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Manufacturer of the investigational device has ceased all business activities). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Background: 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.
- Background: PubMed 29110946Edwards TL, Cottriall CL, Xue K, Simunovic MP, Ramsden JD, Zrenner E, MacLaren RE. Assessment of the Electronic Retinal Implant Alpha AMS in Restoring Vision to Blind Patients with End-Stage Retinitis Pigmentosa. Ophthalmology. 2018 Mar;125(3):432-443. doi: 10.1016/j.ophtha.2017.09.019. Epub 2017 Oct 27.
- Retina Implant AG Sponsor homepageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. If data are shared, this will only be done in a pseudonymized manner.
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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.
Nicolas Leveziel, Prof study chair
Centre Hospitalier Universitaire (CHU) de Poitiers, France
Pierre-André Duval, Dr principal investigator
Clinique Saint Jean, Montpellier, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RETINA IMPLANT Alpha AMS in people with Retinal Degeneration and Inherited Retinal Dystrophy Primarily Involving Sensory Retina, run by Retina Implant AG at 2 sites in France.
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 11 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: stopped early, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 stopped early (reason given: Manufacturer of the investigational device has ceased all business activities). Results are not available in the source record.
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?
Change in functional vision (time frame: baseline vs. 12 months after implantation). 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 NCT03561922, 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 19 Apr 2019.