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Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Safety and Efficacy Multicenter Study (TES/RP)

Primary Purpose

Retinitis Pigmentosa

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcorneal Electrical Stimulation using Okustim device
Sponsored by
Wills Eye
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinitis Pigmentosa focused on measuring Transcorneal Electrical Stimulation, TES, Retinitis Pigmentosa, RP

Eligibility Criteria

22 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with Retinitis Pigmentosa.
  2. Adult patients, 22-80 years of age, having provided written informed consent and HIPAA authorization.
  3. LogMAR VA 1.00 or better in both eyes.
  4. Octopus 900 Central Visual Field ≥10 degrees diameter around central fixation using stimulus sizes III4e and V4e in both eyes on kinetic testing.
  5. Agree to discontinue Vitamin A use and no intake for at least 2 months prior to baseline visit.

Exclusion Criteria:

  1. Visual field loss as demonstrated by Octopus 900 kinetic perimetry as <10 deg of remaining central visual field using stimulus sizes III4e and V4e.
  2. Due to distance or other reason, patients unable to travel to Philadelphia or respective centers for the treatment procedures and follow-up examinations.
  3. Diabetic retinopathy
  4. Ocular neovascularisation of any origin
  5. After arterial or venous occlusion
  6. After retinal detachment or any vitreoretinal surgery with or without implantation.
  7. Silicone oil tamponade
  8. Dry or exudative age-related macular degeneration
  9. Macular edema involving the foveal center as determined by SD-OCT
  10. All forms of glaucoma
  11. Any form of corneal degeneration that reduces visual acuity
  12. Systemic diseases that are difficult to control or manage, which could hinder regular attendance at follow-up examinations
  13. Patients in a permanently poor general condition, which could hinder regular attendance at follow-up examinations
  14. Patients in whom phosphenes are only inducible at greater than, but not including, 0.8 mA.
  15. Forms of mental illness related to the bipolar affective and schizoid-affective disorders, epilepsy, and all forms of dementia
  16. Simultaneous participation in another interventional study or history of interventions whose effect may still persist
  17. 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
  18. Any patient can be excluded from the study as determined by the Principal Investigator.

Sites / Locations

  • Wills Eye Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment group

Sham group

Arm Description

Subjects in the treatment group will undergo bilateral transcorneal electrical stimulation using OkuStim device once a week for fifty-two weeks

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Visual acuity (VA)
VA testing will be done at all visits
Contrast sensitivity
Contrast sensitivity testing will be done at Baseline visit, Week 26, Week 53 and Week 76
NEI-VFQ-25 total score & subscores
NEI-VFQ-25 survey will be filled out at Baseline visit and at Week 53
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

Full Information

First Posted
September 9, 2015
Last Updated
April 29, 2019
Sponsor
Wills Eye
Collaborators
Okuvision GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02548572
Brief Title
Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Safety and Efficacy Multicenter Study
Acronym
TES/RP
Official Title
Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Safety and Efficacy NSR Device Study - A Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Could not recruit patients
Study Start Date
January 2019 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wills Eye
Collaborators
Okuvision GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinitis Pigmentosa
Keywords
Transcorneal Electrical Stimulation, TES, Retinitis Pigmentosa, RP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Subjects in the treatment group will undergo bilateral transcorneal electrical stimulation using OkuStim device once a week for fifty-two weeks
Arm Title
Sham group
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Transcorneal Electrical Stimulation using Okustim device
Intervention Description
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).
Primary Outcome Measure Information:
Title
Octopus vfiii4e (Progressive slowing of Visual Field deterioration)
Description
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
Time Frame
76 weeks
Secondary Outcome Measure Information:
Title
Visual acuity (VA)
Description
VA testing will be done at all visits
Time Frame
76 weeks
Title
Contrast sensitivity
Description
Contrast sensitivity testing will be done at Baseline visit, Week 26, Week 53 and Week 76
Time Frame
76 weeks
Title
NEI-VFQ-25 total score & subscores
Description
NEI-VFQ-25 survey will be filled out at Baseline visit and at Week 53
Time Frame
53 weeks
Title
Photopic b-wave ERG
Description
Photopic b-wave ERG test will be done at Baseline visit, Week 13, Week 26, Week 39, Week 53 and Week 76
Time Frame
76 weeks
Other Pre-specified Outcome Measures:
Title
Change in phosphene threshold detection levels
Description
Change in phosphene threshold detection levels will be done at Screening visit, Baseline visit, Week 13, Week 26, Week 39, Week 53 and Week 76. This is an exploratory efficacy endpoint.
Time Frame
76 weeks
Title
Octopus GATE (static)
Description
Octopus GATE (static) test will be done at Screening visit, Baseline visit, Week 26, Week 53 and Week 76. This is an exploratory efficacy endpoint.
Time Frame
76 weeks
Title
Octopus vf V4e (kinetic)
Description
Octopus vf V4e (kinetic) test will be done at Screening visit, Baseline visit, Week 26, Week 53 and Week 76. This is an exploratory efficacy endpoint.
Time Frame
76 weeks
Title
SD-OCT (ez analysis)
Description
SD-OCT (ez analysis) test will be done at Screening visit, Baseline visit, Week 26, Week 53 and Week 76. This is an exploratory efficacy endpoint.
Time Frame
76 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie Hyman, PhD
Organizational Affiliation
Wills Eye Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Wills Eye Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Safety and Efficacy Multicenter Study

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