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

NCT02548572 | Withdrawn DMC FDA Device

• 1 other identifier: IMC1TES/RP
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinitis Pigmentosa

Keywords

Transcorneal Electrical Stimulation; TES; Retinitis Pigmentosa; RP

Outcome Measures

Primary Outcomes (1)

• 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

  76 weeks

Secondary Outcomes (4)

• Visual acuity (VA)

  76 weeks

• Contrast sensitivity

  76 weeks

• NEI-VFQ-25 total score & subscores

  53 weeks

• Photopic b-wave ERG

  76 weeks

Other Outcomes (4)

• Change in phosphene threshold detection levels

  76 weeks

• Octopus GATE (static)

  76 weeks

• Octopus vf V4e (kinetic)

  76 weeks

Study Arms (2)

Treatment group

EXPERIMENTAL

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

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

Device: Transcorneal Electrical Stimulation using Okustim device

Interventions

Transcorneal Electrical Stimulation using Okustim device 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).

Sham group; Treatment group

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wills Eye: lead
• Okuvision GmbH: collaborator

Study Sites (1)

Wills Eye Health System

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Leslie Hyman, PhD

  Wills Eye Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: September 14, 2015
• Study Start: January 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 1, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)