NCT02548572

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Wills Eye · Academic / Other
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Not accepted

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 - 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.

Conditions

• Retinitis Pigmentosa

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2019-01-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2015-09-14
• Last updated: 2019-05-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study