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Trial record 7 of 140 for:    "Retinitis pigmentosa"

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

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ClinicalTrials.gov Identifier: NCT02548572
Recruitment Status : Suspended (Suspended until further notice)
First Posted : September 14, 2015
Last Update Posted : May 22, 2018
Sponsor:
Collaborator:
Okuvision GmbH
Information provided by (Responsible Party):
Wills Eye

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.

Condition or disease Intervention/treatment Phase
Retinitis Pigmentosa Device: Transcorneal Electrical Stimulation using Okustim device Not Applicable

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 -

  1. VA & Phosphene threshold evaluation
  2. Vfiii4e, vfVe, Octopus 900, complete eye exam, fundus photo, OCT and Contrast sensitivity, electro-physiology.
  3. 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Safety and Efficacy NSR Device Study - A Multicenter Study
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: Treatment group
Subjects in the treatment group will undergo bilateral transcorneal electrical stimulation using OkuStim device once a week for fifty-two weeks
Device: Transcorneal Electrical Stimulation using Okustim device
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).

Placebo Comparator: Sham group
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
Device: Transcorneal Electrical Stimulation using Okustim device
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 Measures :
  1. 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


Secondary Outcome Measures :
  1. Visual acuity (VA) [ Time Frame: 76 weeks ]
    VA testing will be done at all visits

  2. Contrast sensitivity [ Time Frame: 76 weeks ]
    Contrast sensitivity testing will be done at Baseline visit, Week 26, Week 53 and Week 76

  3. NEI-VFQ-25 total score & subscores [ Time Frame: 53 weeks ]
    NEI-VFQ-25 survey will be filled out at Baseline visit and at Week 53

  4. Photopic b-wave ERG [ Time Frame: 76 weeks ]
    Photopic b-wave ERG test will be done at Baseline visit, Week 13, Week 26, Week 39, Week 53 and Week 76


Other Outcome Measures:
  1. Change in phosphene threshold detection levels [ Time Frame: 76 weeks ]
    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.

  2. Octopus GATE (static) [ Time Frame: 76 weeks ]
    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.

  3. Octopus vf V4e (kinetic) [ Time Frame: 76 weeks ]
    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.

  4. SD-OCT (ez analysis) [ Time Frame: 76 weeks ]
    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.



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Ages Eligible for Study:   22 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02548572


Locations
United States, Pennsylvania
Wills Eye Health System
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Wills Eye
Okuvision GmbH
Investigators
Study Director: Leslie Hyman, PhD Wills Eye Hospital

Responsible Party: Wills Eye
ClinicalTrials.gov Identifier: NCT02548572     History of Changes
Other Study ID Numbers: IMC1TES/RP
First Posted: September 14, 2015    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Wills Eye:
Transcorneal Electrical Stimulation
TES
Retinitis Pigmentosa
RP

Additional relevant MeSH terms:
Retinitis
Retinitis Pigmentosa
Cone-Rod Dystrophies
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn