Transcorneal Electrical Stimulation - Multicenter Safety Study

Retinitis Pigmentosa Clinical Trial

Official title:

Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Multicenter Safety Study of the Okustim ® System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01835002
• Other study ID #: TESOLA
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: August 2015

Study information

• Verified date: March 2021
• Source: Okuvision GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to expand the safety assessment of repeated applications of an electrical current from a DTL-like electrode in patients with RP.

Description:

This is a single-arm open label interventional safety trial with RP patients, who receive weekly TES for 6 months on 1 eye followed by observation for another 6 months without stimulation. The primary outcome measure is safety, indicated by the frequency and severity of adverse events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: August 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients with retinitis pigmentosa (rod-cone dystrophy) after prescription of electrical stimulation by an ophthalmologist
• adult patients who are capable of giving consent,
• Visual acuity = 0.02
• because the electrode is to be positioned on the eye at home, the patient or his family members should have sufficient fine motor skills (assessment by the study physician)
• the patient must be capable of giving consent and a medical assessment that he/she is able to participate in the whole study according to the protocol

Exclusion Criteria:

• diabetic retinopathy
• neovascularisation of any origin
• after arterial or venous occlusion
• after retinal detachment
• silicone oil tamponade
• dry or exudative age-related macular degeneration
• macular edema
• all forms of glaucoma
• any form of corneal degeneration that reduces visual acuity
• systemic diseases that are difficult to control or manage, that could endanger the normal study schedule
• patients in a permanently poor general condition, which could hinder the regular attendance at control examinations in the clinic
• forms of mental illness related to the bipolar affective and schizoid-affective disorders, and all forms of dementia
• simultaneous participation in another interventional study or history of interventions whose effect may still persist

Related Conditions & MeSH terms

• Retinitis
• Retinitis Pigmentosa

Intervention

Device:
• Transcorneal electrostimulation
Weekly stimulation for 30 minutes with current of TES delivered of 150% of the individual phosphene threshold.

Locations

Country	Name	City	State
Denmark	Glostrup Hospital and Kennedy Center	Glostrup
Germany	University Eye Clinic Bonn	Bonn
Germany	Augenzentrum München	Munich
Germany	University Eye Clinic Regensburg	Regensburg
Germany	Zentrum für seltene Netzhauterkrankungen, AugenZentrum Siegburg	Siegburg
Germany	Centre for Ophthalmology at the eye clinic Tübingen	Tübingen
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Okuvision GmbH

Countries where clinical trial is conducted

Denmark,  Germany,  Norway, 

References & Publications (6)

Gekeler F; Arbeitsgruppe Elektrostimulation des Department für Augenheilkunde am Universitäts-Klinikum Tübingen. [Transcorneal electrostimulation]. Ophthalmologe. 2012 Feb;109(2):129-35. doi: 10.1007/s00347-011-2450-6. German. — View Citation

Jolly JK, Wagner SK, Martus P, MacLaren RE, Wilhelm B, Webster AR, Downes SM, Charbel Issa P, Kellner U, Jägle H, Rüther K, Bertelsen M, Bragadóttir R, Prener Holtan J, van den Born LI, Sodi A, Virgili G, Gosheva M, Pach J, Zündorf I, Zrenner E, Gekeler F — View Citation

Naycheva L, Schatz A, Röck T, Willmann G, Messias A, Bartz-Schmidt KU, Zrenner E, Gekeler F. Phosphene thresholds elicited by transcorneal electrical stimulation in healthy subjects and patients with retinal diseases. Invest Ophthalmol Vis Sci. 2012 Nov 1;53(12):7440-8. doi: 10.1167/iovs.12-9612. — View Citation

Röck T, Schatz A, Naycheva L, Gosheva M, Pach J, Wilhelm B, Peters T, Bartz-Schmidt KU, Zrenner E, Willmann G, Gekeler F. [Effects of transcorneal electrical stimulation in patients with Stargardt's disease]. Ophthalmologe. 2013 Jan;110(1):68-73. doi: 10.1007/s00347-012-2749-y. German. — View Citation

Schatz A, Arango-Gonzalez B, Fischer D, Enderle H, Bolz S, Röck T, Naycheva L, Grimm C, Messias A, Zrenner E, Bartz-Schmidt KU, Willmann G, Gekeler F. Transcorneal electrical stimulation shows neuroprotective effects in retinas of light-exposed rats. Invest Ophthalmol Vis Sci. 2012 Aug 15;53(9):5552-61. doi: 10.1167/iovs.12-10037. — View Citation

Schatz A, Röck T, Naycheva L, Willmann G, Wilhelm B, Peters T, Bartz-Schmidt KU, Zrenner E, Messias A, Gekeler F. Transcorneal electrical stimulation for patients with retinitis pigmentosa: a prospective, randomized, sham-controlled exploratory study. Invest Ophthalmol Vis Sci. 2011 Jun 23;52(7):4485-96. doi: 10.1167/iovs.10-6932. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ophthalmic examinations	visual acuity slit lamp microscopy for examination of the anterior and posterior segment intraocular pressure measurement visual field examination Optical coherence tomography (OCT) Digital colour fundus photography	6 months
Secondary	Questionnaires	Questionnaires to collect the patient's perceived benefits of treatment and handling of the device	6 months