Retinitis PigmentosaNCT00515814
Retina Implant Pilot Trial to Evaluate Safety & Efficacy in Blind Patients Having Degenerated Photo-receptors
A study testing Retina implant is surgically placed into subretinal position in people with Retinitis Pigmentosa, run by Retina Implant AG at 2 sites in Germany.
Trial summary
The outcome of this trial will reveal the possibilities of the retinal implant to improve the situation of patients with hereditary retinal blindness caused by degenerations of the outer retina. This pilot study will give important information on safety and efficacy of sub-retinal implants. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Retinitis Pigmentosa
- What is being tested?
- Retina implant is surgically placed into subretinal position
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesGermany
- Study dates
- Sep 2005to Dec 2009
- 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
- Hereditary retinal degeneration of the outer retinal layers with the retinal vessels still being perfused and pigments of mild to moderate density
- Blindness (at least monocular) or visual functions not appropriate for navigation/orientation
- Period of appropriate visual functions > 12 years / lifetime
- Visual acuity ≥ 0,05 in earlier life
- Electrically Evoked Phosphenes provide evidence of inner-retinal function.
- willing and able to give written informed consent
Who cannot join
- Any other ophthalmologic disease with relevant effect upon visual function (e.g. glaucoma, optic neuropathy, trauma, diabetic retinopathy, retinal detachment)
- Systemic disease that might imply considerable risk with regard to the surgical intervention and anesthesia (e.g. cardiovascular diseases, severe metabolic diseases)
- Neurological and/or psychiatric diseases (e.g. M. Parkinson, epilepsy, depression )
- Retina detected as too thin (< 100 µm) to expect required rest-functionality as shown via Optical Coherence Tomography (OCT).
- 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 clinical trial within the past 30 days
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Eye Hospital Dresden-Friedrichstadt
Dresden, 01067
University Eye Hospital Tuebingen
Tübingen, 72076
About this study
Official title: A Prospective Open Pilot Study With Functional Placebo-control to Evaluate the Efficacy and Tolerability/Safety of a Subretinal Implant in Blind Patients in Accordance With ICH/GCP Guidelines
The outcome of this trial will reveal the possibilities of the retinal implant to improve the situation of patients with hereditary retinal blindness caused by degenerations of the outer retina. This pilot study will give important information on safety and efficacy of sub-retinal implants.
Read the detailed description
Although the design of the chip with a possible resolution of up to 1500 image points has the potential of providing object recognition, the quality of the image transmitted in this first human application cannot be foreseen. On the other hand clinical experience teaches us that even bare light recognition improves mobility of patients because of the ability to localize bright light sources such as windows or lamps.
- Conditions
- Retinitis Pigmentosa
- Being tested
- Retina implant is surgically placed into subretinal position
- Keywords
- Legal blindness, Retinopathy pigmentosa, Hereditary condition, Photo-receptor degeneration, Retina implant, Subretinal implant
- Medical subject headings
- Retinitis Pigmentosa, Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retina implant is surgically placed into subretinal positionDevice
Also called Retina Implant, subretinal implant, vision prosthesis,, medical device for restoration of vision
Subretinal implant is either in ON or in OFF condition during test periods, such as FrACT, BaLM, grating, orientation \& mobility.
| Study group | Role | What they receive |
|---|---|---|
| 1, 2 | Experimental | During measurement/test periods, investigator sets implant into ON or OFF condition without subjects knowledge of when device is active. Receives: Device: Retina implant is surgically placed into subretinal position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity / Light-perception / Object-orientation are significantly improved with implant-ON versus OFF as shown via FrACT / BaLM / grating test (i.e. EFFICACY)
Measured: within implantation period
Patient treatment shows acceptable results (i.e. SAFETY)
Measured: within implantation period
Secondary outcomes (2)
Activities of Daily Living are significantly improved with implant-ON versus OFF, as shown via Tasks of Daily Living test / Orientation & Mobility test (i.e. EFFICACY)
Measured: within implantation period
Non-acceptable surgical complications will terminate clinical study (i.e. SAFETY)
Measured: within implantation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2007 (estimated)
- Study startSep 2005
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Retina Implant AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eberhart - Zrenner, Prof.Dr.med., Principal investigator, University Eye Hospital Tuebingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515814
- Sponsor's protocol ID
- RI-PT-2005
- Other IDs
- Retina Implant Project
- Status last verified
- Jun 2011
- First submitted
- 13 Aug 2007
- Last updated
- 9 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stingl K, Bartz-Schmidt KU, Gekeler F, Kusnyerik A, Sachs H, Zrenner E. Functional outcome in subretinal electronic implants depends on foveal eccentricity. Invest Ophthalmol Vis Sci. 2013 Nov 19;54(12):7658-65. doi: 10.1167/iovs.13-12835.
PubMed 24150759Kusnyerik A, Greppmaier U, Wilke R, Gekeler F, Wilhelm B, Sachs HG, Bartz-Schmidt KU, Klose U, Stingl K, Resch MD, Hekmat A, Bruckmann A, Karacs K, Nemeth J, Suveges I, Zrenner E. Positioning of electronic subretinal implants in blind retinitis pigmentosa patients through multimodal assessment of retinal structures. Invest Ophthalmol Vis Sci. 2012 Jun 20;53(7):3748-55. doi: 10.1167/iovs.11-9409.
PubMed 22562517Wilke R, Gabel VP, Sachs H, Bartz Schmidt KU, Gekeler F, Besch D, Szurman P, Stett A, Wilhelm B, Peters T, Harscher A, Greppmaier U, Kibbel S, Benav H, Bruckmann A, Stingl K, Kusnyerik A, Zrenner E. Spatial resolution and perception of patterns mediated by a subretinal 16-electrode array in patients blinded by hereditary retinal dystrophies. Invest Ophthalmol Vis Sci. 2011 Jul 29;52(8):5995-6003. doi: 10.1167/iovs.10-6946.
PubMed 21693599
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Open Pilot Study With Functional Placebo-control to Evaluate the Efficacy and Tolerability/Safety of a Subretinal Implant in Blind Patients in Accordance With ICH/GCP Guidelines
- ClinicalTrials.gov ID
- NCT00515814
- Acronym / sponsor ID
- RI-PT-2005
- Conditions
- Retinitis Pigmentosa
- Keywords
- Legal blindness, Retinopathy pigmentosa, Hereditary condition, Photo-receptor degeneration, Retina implant, Subretinal implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Retina Implant AGIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 14 Aug 2007 (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 outcome of this trial will reveal the possibilities of the retinal implant to improve the situation of patients with hereditary retinal blindness caused by degenerations of the outer retina. This pilot study will give important information on safety and efficacy of sub-retinal implants.
Detailed description
Although the design of the chip with a possible resolution of up to 1500 image points has the potential of providing object recognition, the quality of the image transmitted in this first human application cannot be foreseen. On the other hand clinical experience teaches us that even bare light recognition improves mobility of patients because of the ability to localize bright light sources such as windows or lamps.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1, 2 | Experimental | Device: Retina implant is surgically placed into subretinal positionDuring measurement/test periods, investigator sets implant into ON or OFF condition without subjects knowledge of when device is active. |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Hereditary retinal degeneration of the outer retinal layers with the retinal vessels still being perfused and pigments of mild to moderate density
- Blindness (at least monocular) or visual functions not appropriate for navigation/orientation
- Period of appropriate visual functions > 12 years / lifetime
- Visual acuity ≥ 0,05 in earlier life
- Electrically Evoked Phosphenes provide evidence of inner-retinal function.
Key exclusion criteria (6 listed)
- Any other ophthalmologic disease with relevant effect upon visual function (e.g. glaucoma, optic neuropathy, trauma, diabetic retinopathy, retinal detachment)
- Systemic disease that might imply considerable risk with regard to the surgical intervention and anesthesia (e.g. cardiovascular diseases, severe metabolic diseases)
- Neurological and/or psychiatric diseases (e.g. M. Parkinson, epilepsy, depression )
- Retina detected as too thin (< 100 µm) to expect required rest-functionality as shown via Optical Coherence Tomography (OCT).
- 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
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 is surgically placed into subretinal positionAlso: Retina Implant, subretinal implant, vision prosthesis,, medical device for restoration of visionSubretinal implant is either in ON or in OFF condition during test periods, such as FrACT, BaLM, grating, orientation \& mobility. | Device | 1, 2 |
Primary outcome
Visual Acuity / Light-perception / Object-orientation are significantly improved with implant-ON versus OFF as shown via FrACT / BaLM / grating test (i.e. EFFICACY)
Time frame: within implantation period
Patient treatment shows acceptable results (i.e. SAFETY)
Time frame: within implantation period
2 secondary outcomes
Activities of Daily Living are significantly improved with implant-ON versus OFF, as shown via Tasks of Daily Living test / Orientation & Mobility test (i.e. EFFICACY)
Time frame: within implantation period
Non-acceptable surgical complications will terminate clinical study (i.e. SAFETY)
Time frame: within implantation period
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 9 Jun 2011.
- Derived from this study: PubMed 24150759Stingl K, Bartz-Schmidt KU, Gekeler F, Kusnyerik A, Sachs H, Zrenner E. Functional outcome in subretinal electronic implants depends on foveal eccentricity. Invest Ophthalmol Vis Sci. 2013 Nov 19;54(12):7658-65. doi: 10.1167/iovs.13-12835.
- Derived from this study: PubMed 22562517Kusnyerik A, Greppmaier U, Wilke R, Gekeler F, Wilhelm B, Sachs HG, Bartz-Schmidt KU, Klose U, Stingl K, Resch MD, Hekmat A, Bruckmann A, Karacs K, Nemeth J, Suveges I, Zrenner E. Positioning of electronic subretinal implants in blind retinitis pigmentosa patients through multimodal assessment of retinal structures. Invest Ophthalmol Vis Sci. 2012 Jun 20;53(7):3748-55. doi: 10.1167/iovs.11-9409.
- Derived from this study: PubMed 21693599Wilke R, Gabel VP, Sachs H, Bartz Schmidt KU, Gekeler F, Besch D, Szurman P, Stett A, Wilhelm B, Peters T, Harscher A, Greppmaier U, Kibbel S, Benav H, Bruckmann A, Stingl K, Kusnyerik A, Zrenner E. Spatial resolution and perception of patterns mediated by a subretinal 16-electrode array in patients blinded by hereditary retinal dystrophies. Invest Ophthalmol Vis Sci. 2011 Jul 29;52(8):5995-6003. doi: 10.1167/iovs.10-6946.
- patient self-help, support and advocacy organizationLink provided by the sponsor.
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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.
Eberhart - Zrenner, Prof.Dr.med. principal investigator
University Eye Hospital Tuebingen, Germany
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 is surgically placed into subretinal position in people with Retinitis Pigmentosa, run by Retina Implant AG at 2 sites in Germany.
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 6 inclusion and 6 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 9 Jun 2011. 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 Germany. 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?
Visual Acuity / Light-perception / Object-orientation are significantly improved with implant-ON versus OFF as shown via FrACT / BaLM / grating test (i.e. EFFICACY) (time frame: within implantation period). 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?
On the ClinicalTrials.gov record for NCT00515814, which also lists 3 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 9 Jun 2011.