Clinical trial NCT02548572: Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Safety and Efficacy Multicenter Study
Official title: Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Safety and Efficacy NSR Device Study - A Multicenter Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Retinitis Pigmentosa
Keywords: Transcorneal Electrical Stimulation
TES
Retinitis Pigmentosa
RP
Lead sponsor: Wills Eye
Sponsor class: OTHER
Collaborators: name: Okuvision GmbH
First posted: 2015-09-14
Enrollment: 0
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 -

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.

Eligibility 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.

Primary outcomes:
measure: Octopus vfiii4e (Progressive slowing of Visual Field deterioration)
timeFrame: 76 weeks
Secondary outcomes:
measure: Visual acuity (VA)
timeFrame: 76 weeks
measure: Contrast sensitivity
timeFrame: 76 weeks
measure: NEI-VFQ-25 total score & subscores
timeFrame: 53 weeks
measure: Photopic b-wave ERG
timeFrame: 76 weeks
Other outcomes:
measure: Change in phosphene threshold detection levels
timeFrame: 76 weeks
measure: Octopus GATE (static)
timeFrame: 76 weeks
measure: Octopus vf V4e (kinetic)
timeFrame: 76 weeks
measure: SD-OCT (ez analysis)
timeFrame: 76 weeks
Locations:
city: Philadelphia
country: United States
facility: Wills Eye Health System
state: Pennsylvania
Study officials:
affiliation: Wills Eye Hospital
name: Leslie Hyman, PhD
role: STUDY_DIRECTOR
References: