Retinitis Pigmentosa Clinical Trial
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.
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.
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