Retinitis PigmentosaNCT01835002
Transcorneal Electrical Stimulation - Multicenter Safety Study
A study testing Transcorneal electrostimulation in people with Retinitis Pigmentosa, run by Okuvision GmbH at 7 sites in 3 countries.
Trial summary
The purpose of this study is to expand the safety assessment of repeated applications of an electrical current from a DTL-like electrode in patients with RP. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Retinitis Pigmentosa
- What is being tested?
- Transcorneal electrostimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Sep 2012to Aug 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with retinitis pigmentosa (rod-cone dystrophy) after prescription of electrical stimulation by an ophthalmologist
- adult patients who are capable of giving consent,
- Visual acuity ≥ 0.02
- because the electrode is to be positioned on the eye at home, the patient or his family members should have sufficient fine motor skills (assessment by the study physician)
- the patient must be capable of giving consent and a medical assessment that he/she is able to participate in the whole study according to the protocol
Who cannot join
- diabetic retinopathy
- neovascularisation of any origin
- after arterial or venous occlusion
- after retinal detachment
- silicone oil tamponade
- dry or exudative age-related macular degeneration
Show all 13Show fewer
- macular edema
- all forms of glaucoma
- any form of corneal degeneration that reduces visual acuity
- systemic diseases that are difficult to control or manage, that could endanger the normal study schedule
- patients in a permanently poor general condition, which could hinder the regular attendance at control examinations in the clinic
- forms of mental illness related to the bipolar affective and schizoid-affective disorders, and all forms of dementia
- simultaneous participation in another interventional study or history of interventions whose effect may still persist
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Germany5 sites
University Eye Clinic Bonn
Bonn, 53127
Augenzentrum München
Munich
University Eye Clinic Regensburg
Regensburg, 93053
Zentrum für seltene Netzhauterkrankungen, AugenZentrum Siegburg
Siegburg, 53721
Centre for Ophthalmology at the eye clinic Tübingen
Tübingen, 72076
About this study
Official title: Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Multicenter Safety Study of the Okustim ® System
The purpose of this study is to expand the safety assessment of repeated applications of an electrical current from a DTL-like electrode in patients with RP.
Read the detailed description
This is a single-arm open label interventional safety trial with RP patients, who receive weekly TES for 6 months on 1 eye followed by observation for another 6 months without stimulation. The primary outcome measure is safety, indicated by the frequency and severity of adverse events.
- Conditions
- Retinitis Pigmentosa
- Being tested
- Transcorneal electrostimulation
- Keywords
- transcorneal electrostimulation
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcorneal electrostimulationDevice
Also called OkuStim, TES, TcES
Weekly stimulation for 30 minutes with current of TES delivered of 150% of the individual phosphene threshold.
| Study group | Role | What they receive |
|---|---|---|
| OkuStim | Experimental | Electrostimulation Standard Treatment with OkuStim Receives: Device: Transcorneal electrostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ophthalmic examinations
visual acuity slit lamp microscopy for examination of the anterior and posterior segment intraocular pressure measurement visual field examination Optical coherence tomography (OCT) Digital colour fundus photography
Measured: 6 months
Secondary outcomes (1)
Questionnaires
Questionnaires to collect the patient's perceived benefits of treatment and handling of the device
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study startSep 2012
- Primary completionJul 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okuvision GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Florian Gekeler, Prof Dr med, Principal investigator, Eberhard-Karls-Universität Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01835002
- Sponsor's protocol ID
- TESOLA
- Status last verified
- Mar 2021
- First submitted
- 15 Apr 2013
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Naycheva L, Schatz A, Rock T, Willmann G, Messias A, Bartz-Schmidt KU, Zrenner E, Gekeler F. Phosphene thresholds elicited by transcorneal electrical stimulation in healthy subjects and patients with retinal diseases. Invest Ophthalmol Vis Sci. 2012 Nov 1;53(12):7440-8. doi: 10.1167/iovs.12-9612.
PubMed 23049087Gekeler F; Arbeitsgruppe Elektrostimulation des Department fur Augenheilkunde am Universitats-Klinikum Tubingen. [Transcorneal electrostimulation]. Ophthalmologe. 2012 Feb;109(2):129-35. doi: 10.1007/s00347-011-2450-6. German.
PubMed 22350549Schatz A, Rock T, Naycheva L, Willmann G, Wilhelm B, Peters T, Bartz-Schmidt KU, Zrenner E, Messias A, Gekeler F. Transcorneal electrical stimulation for patients with retinitis pigmentosa: a prospective, randomized, sham-controlled exploratory study. Invest Ophthalmol Vis Sci. 2011 Jun 23;52(7):4485-96. doi: 10.1167/iovs.10-6932.
PubMed 21467183Schatz A, Arango-Gonzalez B, Fischer D, Enderle H, Bolz S, Rock T, Naycheva L, Grimm C, Messias A, Zrenner E, Bartz-Schmidt KU, Willmann G, Gekeler F. Transcorneal electrical stimulation shows neuroprotective effects in retinas of light-exposed rats. Invest Ophthalmol Vis Sci. 2012 Aug 15;53(9):5552-61. doi: 10.1167/iovs.12-10037.
PubMed 22807300Rock T, Schatz A, Naycheva L, Gosheva M, Pach J, Wilhelm B, Peters T, Bartz-Schmidt KU, Zrenner E, Willmann G, Gekeler F. [Effects of transcorneal electrical stimulation in patients with Stargardt's disease]. Ophthalmologe. 2013 Jan;110(1):68-73. doi: 10.1007/s00347-012-2749-y. German.
PubMed 23329121Jolly JK, Wagner SK, Martus P, MacLaren RE, Wilhelm B, Webster AR, Downes SM, Charbel Issa P, Kellner U, Jagle H, Ruther K, Bertelsen M, Bragadottir R, Prener Holtan J, van den Born LI, Sodi A, Virgili G, Gosheva M, Pach J, Zundorf I, Zrenner E, Gekeler F. Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa: A Multicenter Safety Study of the OkuStim(R) System (TESOLA-Study). Ophthalmic Res. 2020;63(3):234-243. doi: 10.1159/000505001. Epub 2019 Nov 26.
PubMed 31775146
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Multicenter Safety Study of the Okustim ® System
- ClinicalTrials.gov ID
- NCT01835002
- Acronym / sponsor ID
- TESOLA
- Conditions
- Retinitis Pigmentosa
- Keywords
- transcorneal electrostimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Okuvision GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 18 Apr 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 purpose of this study is to expand the safety assessment of repeated applications of an electrical current from a DTL-like electrode in patients with RP.
Detailed description
This is a single-arm open label interventional safety trial with RP patients, who receive weekly TES for 6 months on 1 eye followed by observation for another 6 months without stimulation. The primary outcome measure is safety, indicated by the frequency and severity of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OkuStim | Experimental | Device: Transcorneal electrostimulationElectrostimulation Standard Treatment with OkuStim |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients with retinitis pigmentosa (rod-cone dystrophy) after prescription of electrical stimulation by an ophthalmologist
- adult patients who are capable of giving consent,
- Visual acuity ≥ 0.02
- because the electrode is to be positioned on the eye at home, the patient or his family members should have sufficient fine motor skills (assessment by the study physician)
- the patient must be capable of giving consent and a medical assessment that he/she is able to participate in the whole study according to the protocol
Key exclusion criteria (13 listed)
- diabetic retinopathy
- neovascularisation of any origin
- after arterial or venous occlusion
- after retinal detachment
- silicone oil tamponade
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 |
|---|---|---|
| Transcorneal electrostimulationAlso: OkuStim, TES, TcESWeekly stimulation for 30 minutes with current of TES delivered of 150% of the individual phosphene threshold. | Device | OkuStim |
Primary outcome
ophthalmic examinations
Time frame: 6 months
visual acuity slit lamp microscopy for examination of the anterior and posterior segment intraocular pressure measurement visual field examination Optical coherence tomography (OCT) Digital colour fundus photography
1 secondary outcome
Questionnaires
Time frame: 6 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 4 Mar 2021.
- Background: PubMed 23049087Naycheva L, Schatz A, Rock T, Willmann G, Messias A, Bartz-Schmidt KU, Zrenner E, Gekeler F. Phosphene thresholds elicited by transcorneal electrical stimulation in healthy subjects and patients with retinal diseases. Invest Ophthalmol Vis Sci. 2012 Nov 1;53(12):7440-8. doi: 10.1167/iovs.12-9612.
- Background: PubMed 22350549Gekeler F; Arbeitsgruppe Elektrostimulation des Department fur Augenheilkunde am Universitats-Klinikum Tubingen. [Transcorneal electrostimulation]. Ophthalmologe. 2012 Feb;109(2):129-35. doi: 10.1007/s00347-011-2450-6. German.
- Background: PubMed 21467183Schatz A, Rock T, Naycheva L, Willmann G, Wilhelm B, Peters T, Bartz-Schmidt KU, Zrenner E, Messias A, Gekeler F. Transcorneal electrical stimulation for patients with retinitis pigmentosa: a prospective, randomized, sham-controlled exploratory study. Invest Ophthalmol Vis Sci. 2011 Jun 23;52(7):4485-96. doi: 10.1167/iovs.10-6932.
- Background: PubMed 22807300Schatz A, Arango-Gonzalez B, Fischer D, Enderle H, Bolz S, Rock T, Naycheva L, Grimm C, Messias A, Zrenner E, Bartz-Schmidt KU, Willmann G, Gekeler F. Transcorneal electrical stimulation shows neuroprotective effects in retinas of light-exposed rats. Invest Ophthalmol Vis Sci. 2012 Aug 15;53(9):5552-61. doi: 10.1167/iovs.12-10037.
- Background: PubMed 23329121Rock T, Schatz A, Naycheva L, Gosheva M, Pach J, Wilhelm B, Peters T, Bartz-Schmidt KU, Zrenner E, Willmann G, Gekeler F. [Effects of transcorneal electrical stimulation in patients with Stargardt's disease]. Ophthalmologe. 2013 Jan;110(1):68-73. doi: 10.1007/s00347-012-2749-y. German.
- Results publication: PubMed 31775146Jolly JK, Wagner SK, Martus P, MacLaren RE, Wilhelm B, Webster AR, Downes SM, Charbel Issa P, Kellner U, Jagle H, Ruther K, Bertelsen M, Bragadottir R, Prener Holtan J, van den Born LI, Sodi A, Virgili G, Gosheva M, Pach J, Zundorf I, Zrenner E, Gekeler F. Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa: A Multicenter Safety Study of the OkuStim(R) System (TESOLA-Study). Ophthalmic Res. 2020;63(3):234-243. doi: 10.1159/000505001. Epub 2019 Nov 26.
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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.
Florian Gekeler, Prof Dr med principal investigator
Eberhard-Karls-Universität Tübingen
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcorneal electrostimulation in people with Retinitis Pigmentosa, run by Okuvision GmbH at 7 sites in 3 countries.
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 5 inclusion and 13 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 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Denmark, Norway. 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?
ophthalmic examinations (time frame: 6 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 NCT01835002, which also lists 6 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 4 Mar 2021.