Retinitis PigmentosaTES/RPNCT02548572
Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Safety and Efficacy Multicenter Study
A study testing Transcorneal Electrical Stimulation using Okustim device in people with Retinitis Pigmentosa, run by Wills Eye at 1 site in United States.
Trial summary
Several studies have shown that TES in RP patients may help to slow the progressive deterioration of this degenerative disease. The end point of this clinical trial is to slow or stop disease progression with weekly treatment using TES for 1 year. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Retinitis Pigmentosa
- What is being tested?
- Transcorneal Electrical Stimulation using Okustim device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2019to Dec 2020
- 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 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Retinitis Pigmentosa.
- Adult patients, 22-80 years of age, having provided written informed consent and HIPAA authorization.
- LogMAR VA 1.00 or better in both eyes.
- Octopus 900 Central Visual Field ≥10 degrees diameter around central fixation using stimulus sizes III4e and V4e in both eyes on kinetic testing.
- Agree to discontinue Vitamin A use and no intake for at least 2 months prior to baseline visit.
Who cannot join
- Visual field loss as demonstrated by Octopus 900 kinetic perimetry as <10 deg of remaining central visual field using stimulus sizes III4e and V4e.
- Due to distance or other reason, patients unable to travel to Philadelphia or respective centers for the treatment procedures and follow-up examinations.
- Diabetic retinopathy
- Ocular neovascularisation of any origin
- After arterial or venous occlusion
- After retinal detachment or any vitreoretinal surgery with or without implantation.
Show all 18Show fewer
- Silicone oil tamponade
- Dry or exudative age-related macular degeneration
- Macular edema involving the foveal center as determined by SD-OCT
- All forms of glaucoma
- Any form of corneal degeneration that reduces visual acuity
- Systemic diseases that are difficult to control or manage, which could hinder regular attendance at follow-up examinations
- Patients in a permanently poor general condition, which could hinder regular attendance at follow-up examinations
- Patients in whom phosphenes are only inducible at greater than, but not including, 0.8 mA.
- Forms of mental illness related to the bipolar affective and schizoid-affective disorders, epilepsy, and all forms of dementia
- Simultaneous participation in another interventional study or history of interventions whose effect may still persist
- Current pregnancy, or being a woman with childbearing potential who is unwilling to use medically acceptable means of birth control for the study duration, or a woman unwilling to perform a pregnancy test at study entry
- Any patient can be excluded from the study as determined by the Principal Investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wills Eye Health System
Philadelphia, Pennsylvania, 19107
About this study
Official title: Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Safety and Efficacy NSR Device Study - A Multicenter Study
Several studies have shown that TES in RP patients may help to slow the progressive deterioration of this degenerative disease. The end point of this clinical trial is to slow or stop disease progression with weekly treatment using TES for 1 year.
Read the detailed description
The following proposed study (ICM1TES/RP) will investigate the therapeutic aspects of transcorneal electrical stimulation (TES) on the eye in patients with retinitis pigmentosa (RP). It will utilize the Okuvision TES system, a Wills Eye Hospital-sponsored FDA non-significant risk (NSR) medical device, OkuStim® (CE-marked OkuStim®) for the application of electrical stimulation directly to the eye via a corneal contact electrode.
Study Design - Multi-center, prospective, randomized sham controlled 1:1 Clinical trial.
Study treatments - Patients will be randomized in a 1:1 ratio. Patients in treatment group will have TES at 200% of phosphene threshold for 30 minutes once weekly for 52 weeks in both eyes. Patients in sham group will also wear electrodes on both eyes, but no energy is turned on and both eyes are sham.
Duration of study - anticipated duration is 36 months, 12 months for recruitment, 12 months for treatment and sham groups and followed for 18 months, plus 6 months for analysis.
Inclusion Criteria - Diagnosis of RP, 22-80 years of age, no other ocular disease, able to complete all visits.
Treatments - TES, 30 minute treatment weekly for 52 weeks at 0.8mA
Number of patients - 90 patients in treatment arm and 90 patients in sham arm. Electrodes will be placed on both eyes, both eyes will be treated in treatment group and in the sham group both eyes will be considered. However due to the possibility of drop out using 15% we will recruit 210 patients (15 patients per center).
Screening -
- VA \& Phosphene threshold evaluation
- Vfiii4e, vfVe, Octopus 900, complete eye exam, fundus photo, OCT and Contrast sensitivity, electro-physiology.
- Eligibility requirements met, then schedule baseline.
Tests - Base Line: VA, vfiii4e, vfVe, Octopus 900, complete eye exam, fundus photo, OCT, Contrast sensitivity, NEI VFQ-25, Photopic B-wave ERG, blood draw for genetic test (unless genetic profile has been done).
3 Month visit: VA, eye exam, Phosphene threshold, OCT \& Photopic B-wave.
6 Month visit: VA, vfiii4e, vfVe, Octopus 900, complete eye exam, OCT \& Contrast sensitivity, phosphine threshold \& Photopic B-wave.
9 Month visit: VA, eye exam, Phosphene threshold, OCT \& Photopic B-wave.
12 Month visit: VA, vfiii4e, vfVe, Octopus 900, complete eye exam, OCT \& Contrast sensitivity, NEI VFQ-25, phosphene threshold \& Photopic B-wave
18 Month visit: VA, vfiii4e, vfVe, Octopus 900, complete eye exam, OCT \& Contrast sensitivity, NEI VFQ-25 \& phosphene threshold \& Photopic B-wave.
- Conditions
- Retinitis Pigmentosa
- Being tested
- Transcorneal Electrical Stimulation using Okustim device
- Keywords
- Transcorneal Electrical Stimulation, TES, Retinitis Pigmentosa, RP
- 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 Electrical Stimulation using Okustim deviceDevice
The Okustim® stimulation device is a battery-powered electronic neuro-stimulator, which delivers a weak electrical pulse. This current is delivered to the eyes by the OkuStim® device using the "OkuEl®" electrodes, which are held in place via the "OkuSpex®" frame. In this study the treatment level will be held constant at 0.8 mA for all study subjects. After switching on the neuro-stimulator, the subject's retina will be stimulated through specific electrodes (OkuEl, held in position by the OkuSpex) worn on the face with the predetermined intensity and time period (delivered by the OkuStim device).
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Subjects in the treatment group will undergo bilateral transcorneal electrical stimulation using OkuStim device once a week for fifty-two weeks Receives: Device: Transcorneal Electrical Stimulation using Okustim device |
| Sham group | Placebo comparator | Subjects in the Sham group will wear the OkuSpex and OkuEl (applied to cornea upon the lower lid) and be attached to the OkuStim device in the same manner as the treatment group, but will receive no electrical stimulation for the 30 minutes that the TES fiber is applied to the cornea (even though the device has been turned on) once a week for fifty-two weeks Receives: Device: Transcorneal Electrical Stimulation using Okustim device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Octopus vfiii4e (Progressive slowing of Visual Field deterioration)
Octopus vfiii4e test will be done at Screening visit, Baseline visit, Week 26, Week 53 and Week 76 to analyze progressive slowing of Visual Field deterioration
Measured: 76 weeks
Secondary outcomes (4)
Visual acuity (VA)
VA testing will be done at all visits
Measured: 76 weeks
Contrast sensitivity
Contrast sensitivity testing will be done at Baseline visit, Week 26, Week 53 and Week 76
Measured: 76 weeks
NEI-VFQ-25 total score & subscores
NEI-VFQ-25 survey will be filled out at Baseline visit and at Week 53
Measured: 53 weeks
Photopic b-wave ERG
Photopic b-wave ERG test will be done at Baseline visit, Week 13, Week 26, Week 39, Week 53 and Week 76
Measured: 76 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study startJan 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Could not recruit patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Collaborators
- Okuvision GmbH
- Responsible party
- Sponsor
- Investigators
- Leslie Hyman, PhD, Study director, Wills Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548572
- Sponsor's protocol ID
- IMC1TES/RP
- Acronym
- TES/RP
- Status last verified
- Apr 2019
- First submitted
- 9 Sep 2015
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. 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 Safety and Efficacy NSR Device Study - A Multicenter Study
- ClinicalTrials.gov ID
- NCT02548572
- Acronym / sponsor ID
- TES/RP / IMC1TES/RP
- Conditions
- Retinitis Pigmentosa
- Keywords
- Transcorneal Electrical Stimulation, TES, Retinitis Pigmentosa, RP
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Could not recruit patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Collaborators
- Okuvision GmbH
- Study start
- Jan 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 14 Sep 2015 (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.
Several studies have shown that TES in RP patients may help to slow the progressive deterioration of this degenerative disease. The end point of this clinical trial is to slow or stop disease progression with weekly treatment using TES for 1 year.
Detailed description
The following proposed study (ICM1TES/RP) will investigate the therapeutic aspects of transcorneal electrical stimulation (TES) on the eye in patients with retinitis pigmentosa (RP). It will utilize the Okuvision TES system, a Wills Eye Hospital-sponsored FDA non-significant risk (NSR) medical device, OkuStim® (CE-marked OkuStim®) for the application of electrical stimulation directly to the eye via a corneal contact electrode.
Study Design - Multi-center, prospective, randomized sham controlled 1:1 Clinical trial.
Study treatments - Patients will be randomized in a 1:1 ratio. Patients in treatment group will have TES at 200% of phosphene threshold for 30 minutes once weekly for 52 weeks in both eyes. Patients in sham group will also wear electrodes on both eyes, but no energy is turned on and both eyes are sham.
Duration of study - anticipated duration is 36 months, 12 months for recruitment, 12 months for treatment and sham groups and followed for 18 months, plus 6 months for analysis.
Inclusion Criteria - Diagnosis of RP, 22-80 years of age, no other ocular disease, able to complete all visits.
Treatments - TES, 30 minute treatment weekly for 52 weeks at 0.8mA
Number of patients - 90 patients in treatment arm and 90 patients in sham arm. Electrodes will be placed on both eyes, both eyes will be treated in treatment group and in the sham group both eyes will be considered. However due to the possibility of drop out using 15% we will recruit 210 patients (15 patients per center).
Screening -
- VA \& Phosphene threshold evaluation
- Vfiii4e, vfVe, Octopus 900, complete eye exam, fundus photo, OCT and Contrast sensitivity, electro-physiology.
- Eligibility requirements met, then schedule baseline.
Tests - Base Line: VA, vfiii4e, vfVe, Octopus 900, complete eye exam, fundus photo, OCT, Contrast sensitivity, NEI VFQ-25, Photopic B-wave ERG, blood draw for genetic test (unless genetic profile has been done).
3 Month visit: VA, eye exam, Phosphene threshold, OCT \& Photopic B-wave.
6 Month visit: VA, vfiii4e, vfVe, Octopus 900, complete eye exam, OCT \& Contrast sensitivity, phosphine threshold \& Photopic B-wave.
9 Month visit: VA, eye exam, Phosphene threshold, OCT \& Photopic B-wave.
12 Month visit: VA, vfiii4e, vfVe, Octopus 900, complete eye exam, OCT \& Contrast sensitivity, NEI VFQ-25, phosphene threshold \& Photopic B-wave
18 Month visit: VA, vfiii4e, vfVe, Octopus 900, complete eye exam, OCT \& Contrast sensitivity, NEI VFQ-25 \& phosphene threshold \& Photopic B-wave.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Transcorneal Electrical Stimulation using Okustim deviceSubjects in the treatment group will undergo bilateral transcorneal electrical stimulation using OkuStim device once a week for fifty-two weeks |
| Sham group | Placebo comparator | Device: Transcorneal Electrical Stimulation using Okustim deviceSubjects in the Sham group will wear the OkuSpex and OkuEl (applied to cornea upon the lower lid) and be attached to the OkuStim device in the same manner as the treatment group, but will receive no electrical stimulation for the 30 minutes that the TES fiber is applied to the cornea (even though the device has been turned on) once a week for fifty-two weeks |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with Retinitis Pigmentosa.
- Adult patients, 22-80 years of age, having provided written informed consent and HIPAA authorization.
- LogMAR VA 1.00 or better in both eyes.
- Octopus 900 Central Visual Field ≥10 degrees diameter around central fixation using stimulus sizes III4e and V4e in both eyes on kinetic testing.
- Agree to discontinue Vitamin A use and no intake for at least 2 months prior to baseline visit.
Key exclusion criteria (18 listed)
- Visual field loss as demonstrated by Octopus 900 kinetic perimetry as <10 deg of remaining central visual field using stimulus sizes III4e and V4e.
- Due to distance or other reason, patients unable to travel to Philadelphia or respective centers for the treatment procedures and follow-up examinations.
- Diabetic retinopathy
- Ocular neovascularisation of any origin
- After arterial or venous occlusion
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 Electrical Stimulation using Okustim deviceThe Okustim® stimulation device is a battery-powered electronic neuro-stimulator, which delivers a weak electrical pulse. This current is delivered to the eyes by the OkuStim® device using the "OkuEl®" electrodes, which are held in place via the "OkuSpex®" frame. In this study the treatment level will be held constant at 0.8 mA for all study subjects. After switching on the neuro-stimulator, the subject's retina will be stimulated through specific electrodes (OkuEl, held in position by the OkuSpex) worn on the face with the predetermined intensity and time period (delivered by the OkuStim device). | Device | Sham group, Treatment group |
Primary outcome
Octopus vfiii4e (Progressive slowing of Visual Field deterioration)
Time frame: 76 weeks
Octopus vfiii4e test will be done at Screening visit, Baseline visit, Week 26, Week 53 and Week 76 to analyze progressive slowing of Visual Field deterioration
4 secondary outcomes
Visual acuity (VA)
Time frame: 76 weeks
Contrast sensitivity
Time frame: 76 weeks
NEI-VFQ-25 total score & subscores
Time frame: 53 weeks
Photopic b-wave ERG
Time frame: 76 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Individual participant dataSharing planned: Yes
Related trials for Retinitis Pigmentosa
RecruitingObservational study
Rod and Cone Mediated Function in Retinal Disease
Retinal Degeneration, Retinitis Pigmentosa
RecruitingObservational study
Cell Collection to Study Eye Diseases
Retinal Disease, AMD
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
RecruitingObservational study
Universal Rare Gene Study: A Registry and Natural History Study of Retinal Dystrophies Associated With Rare Disease-Causing Genetic Variants
Inherited Retinal Degeneration, Retinitis Pigmentosa
Active, not recruitingObservational study
Rate of Progression in EYS Related Retinal Degeneration
Retinitis Pigmentosa, Eye Diseases
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.
Leslie Hyman, PhD study director
Wills Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcorneal Electrical Stimulation using Okustim device in people with Retinitis Pigmentosa, run by Wills Eye at 1 site in United States.
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 18 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: withdrawn, as of the sponsor's last update on 1 May 2019. 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 States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Octopus vfiii4e (Progressive slowing of Visual Field deterioration) (time frame: 76 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2019.