Retinal DegenerationNCT01497379
Safety & Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients
A study testing surgical implantation of subretinal device in people with Retinal Degeneration and Retinitis Pigmentosa, run by Retina Implant AG at 1 site in Hong Kong.
Trial summary
Patients who are legally blind, caused by retinal degeneration of photoreceptor rods \& cones (e.g. Retinitis pigmentosa), receive a subretinal implant to restore vision partially. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Retinal Degeneration, Retinitis Pigmentosa
- What is being tested?
- surgical implantation of subretinal device
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteHong Kong
- Study dates
- Oct 2011to Jan 2015
- 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 i.e. photoreceptor rods \& cones.
- Pseudophakia
- Angiography shows retinal vessels adequately perfused, despite pathological RP condition.
- Age between 18 and 78 years.
- Blindness (at least monocular) i.e. visual functions not appropriate for localization of objects, self sustained navigation and orientation (impaired light localization or worse).
- Ability to read normal print in earlier life, optically corrected without magnifying glass.
- Willing and able to give written informed consent in accordance to EN ISO 14155 (section 6.7) and local legislation prior to participation in the study. Able to perform the study during the full time period of one year
Who cannot join
- Period of appropriate visual functions < 12 years / lifetime.
- Optical Coherence Tomography (OCT) shows significant retina edema \&/or scar tissue within target region for implant.
- Retina detected as too thin to expect required rest-functionality of inner retina as shown via Optical Coherence Tomography (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 on eye to be implanted
- Systemic diseases that might imply considerable risks with regard to the surgical interventions and anaesthesia (e.g. cardiovascular/ pulmonary diseases, severe metabolic diseases).
- Neurological and/or psychiatric diseases (e.g. M. Parkinson, epilepsy, depression).
- Hyperthyroidism or hypersensitivity to iodine
- 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 trial within the past 30 days.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Ophthalmology Eye Institute, University of Hong Kong
Hong Kong, Cyberport, 100
About this study
Official title: Safety & Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients: A Prospective Mono- & Multicenter Clinical Study Based on Randomized Intra-individual Implant Activation in Degenerative Retinal Disease Patients.
Patients who are legally blind, caused by retinal degeneration of photoreceptor rods \& cones (e.g. Retinitis pigmentosa), receive a subretinal implant to restore vision partially.
- Conditions
- Retinal Degeneration, Retinitis Pigmentosa
- Being tested
- surgical implantation of subretinal device
- Keywords
- Hereditary retinal, degeneration outer, retinal layers, photoreceptor rods cones, Retinitis pigmentosa, blindness, reading ability, retina implant, subretinal
- Medical subject headings
- Retinal Degeneration, Retinitis Pigmentosa, Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical implantation of subretinal deviceProcedure or surgery
Also called Retinal implant, subretinal implant
surgical implantation of subretinal device
surgical implantation of subretinal deviceProcedure or surgery
Also called Retinal implant, subretinal implant
intra-individual implant OFF
| Study group | Role | What they receive |
|---|---|---|
| intra-individual implant ON | Experimental | intra-individual implant activation Receives: Procedure: surgical implantation of subretinal device |
| intra-individual implant OFF | Placebo comparator | intra-individual implant deactivation Receives: Procedure: surgical implantation of subretinal device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
treatment shows no permanent damage of function and structures that have been functional before surgery and no permanent damage to health and/or well being of patients
Measured: 1 year
Efficacy
Activities of Daily Living \& Mobility are significantly improved with implant-ON versus OFF, as shown via tests:
- Activities of Daily Living tasks or
- Recognition tasks or
- Mobility or
- a combination of the above
Measured: 1 year
Secondary outcomes (2)
Safety
Patient long term safety:
- stability of implant function
- stability of body structure \& function related to implant system
Measured: 1 year
Efficacy
Visual Acuity / Light-perception and/or Object-recognition are significantly improved with implant-ON versus OFF as shown via:
- FrACT or
- BaLM or
- Grating test (e.g. BaGA) and/or Quality of life
- Quality of life (questionnaire) or
- a combination of the above
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 posted22 Dec 2011 (estimated)
- Study startOct 2011
- Primary completionJan 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Retina Implant AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Wong, Prof., MD, Principal investigator, Chair Professor in Ophthalmology Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497379
- Sponsor's protocol ID
- HKCTR-1198
- Other IDs
- RI-MC-CT-2009
- Status last verified
- Mar 2017
- First submitted
- 15 Dec 2011
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stingl K, Bartz-Schmidt KU, Besch D, Chee CK, Cottriall CL, Gekeler F, Groppe M, Jackson TL, MacLaren RE, Koitschev A, Kusnyerik A, Neffendorf J, Nemeth J, Naeem MA, Peters T, Ramsden JD, Sachs H, Simpson A, Singh MS, Wilhelm B, Wong D, Zrenner E. Subretinal Visual Implant Alpha IMS--Clinical trial interim report. Vision Res. 2015 Jun;111(Pt B):149-60. doi: 10.1016/j.visres.2015.03.001. Epub 2015 Mar 23.
PubMed 25812924
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety & Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients: A Prospective Mono- & Multicenter Clinical Study Based on Randomized Intra-individual Implant Activation in Degenerative Retinal Disease Patients.
- ClinicalTrials.gov ID
- NCT01497379
- Acronym / sponsor ID
- HKCTR-1198
- Conditions
- Retinal Degeneration, Retinitis Pigmentosa
- Keywords
- Hereditary retinal, degeneration outer, retinal layers, photoreceptor rods cones, Retinitis pigmentosa, blindness, reading ability, retina implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Retina Implant AGIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 22 Dec 2011 (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.
Patients who are legally blind, caused by retinal degeneration of photoreceptor rods \& cones (e.g. Retinitis pigmentosa), receive a subretinal implant to restore vision partially.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intra-individual implant ON | Experimental | Procedure: surgical implantation of subretinal deviceintra-individual implant activation |
| intra-individual implant OFF | Placebo comparator | Procedure: surgical implantation of subretinal deviceintra-individual implant deactivation |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Hereditary retinal degeneration of the outer retinal layers i.e. photoreceptor rods \& cones.
- Pseudophakia
- Angiography shows retinal vessels adequately perfused, despite pathological RP condition.
- Age between 18 and 78 years.
- Blindness (at least monocular) i.e. visual functions not appropriate for localization of objects, self sustained navigation and orientation (impaired light localization or worse).
Key exclusion criteria (12 listed)
- Period of appropriate visual functions < 12 years / lifetime.
- Optical Coherence Tomography (OCT) shows significant retina edema \&/or scar tissue within target region for implant.
- Retina detected as too thin to expect required rest-functionality of inner retina as shown via Optical Coherence Tomography (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 |
|---|---|---|
| surgical implantation of subretinal deviceAlso: Retinal implant, subretinal implantsurgical implantation of subretinal device | Procedure or surgery | intra-individual implant ON |
| surgical implantation of subretinal deviceAlso: Retinal implant, subretinal implantintra-individual implant OFF | Procedure or surgery | intra-individual implant OFF |
Primary outcome
Safety
Time frame: 1 year
treatment shows no permanent damage of function and structures that have been functional before surgery and no permanent damage to health and/or well being of patients
Efficacy
Time frame: 1 year
Activities of Daily Living \& Mobility are significantly improved with implant-ON versus OFF, as shown via tests: * Activities of Daily Living tasks or * Recognition tasks or * Mobility or * a combination of the above
2 secondary outcomes
Safety
Time frame: 1 year
Efficacy
Time frame: 1 year
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 29 Mar 2017.
- Results publication: PubMed 25812924Stingl K, Bartz-Schmidt KU, Besch D, Chee CK, Cottriall CL, Gekeler F, Groppe M, Jackson TL, MacLaren RE, Koitschev A, Kusnyerik A, Neffendorf J, Nemeth J, Naeem MA, Peters T, Ramsden JD, Sachs H, Simpson A, Singh MS, Wilhelm B, Wong D, Zrenner E. Subretinal Visual Implant Alpha IMS--Clinical trial interim report. Vision Res. 2015 Jun;111(Pt B):149-60. doi: 10.1016/j.visres.2015.03.001. Epub 2015 Mar 23.
- Hong Kong clinical trials registryLink 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.
David Wong, Prof., MD principal investigator
Chair Professor in Ophthalmology 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 surgical implantation of subretinal device in people with Retinal Degeneration and Retinitis Pigmentosa, run by Retina Implant AG at 1 site in Hong Kong.
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 7 inclusion and 12 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 29 Mar 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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?
Safety (time frame: 1 year). 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 NCT01497379, which also lists 1 linked publication.
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 29 Mar 2017.