Clinical trial NCT01835002: Transcorneal Electrical Stimulation - Multicenter Safety Study
Official title: Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Multicenter Safety Study of the Okustim ® System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinitis Pigmentosa
Keywords: transcorneal electrostimulation
Lead sponsor: Okuvision GmbH
Sponsor class: INDUSTRY
First posted: 2013-04-18
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: ophthalmic examinations
timeFrame: 6 months
Secondary outcomes:
measure: Questionnaires
timeFrame: 6 months
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Glostrup Hospital and Kennedy Center
city: Bonn
country: Germany
facility: University Eye Clinic Bonn
city: Munich
country: Germany
facility: Augenzentrum München
city: Regensburg
country: Germany
facility: University Eye Clinic Regensburg
city: Siegburg
country: Germany
facility: Zentrum für seltene Netzhauterkrankungen, AugenZentrum Siegburg
city: Tübingen
country: Germany
facility: Centre for Ophthalmology at the eye clinic Tübingen
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Eberhard-Karls-Universität Tübingen
name: Florian Gekeler, Prof Dr med
role: PRINCIPAL_INVESTIGATOR
References:
citation: Naycheva L, Schatz A, Rock 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.
citation: Gekeler F; Arbeitsgruppe Elektrostimulation des Department fur Augenheilkunde am Universitats-Klinikum Tubingen. [Transcorneal electrostimulation]. Ophthalmologe. 2012 Feb;109(2):129-35. doi: 10.1007/s00347-011-2450-6. German.
citation: Schatz A, Rock 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.
citation: Schatz A, Arango-Gonzalez B, Fischer D, Enderle H, Bolz S, Rock 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.
citation: Rock 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.
citation: Jolly JK, Wagner SK, Martus P, MacLaren RE, Wilhelm B, Webster AR, Downes SM, Charbel Issa P, Kellner U, Jagle H, Ruther K, Bertelsen M, Bragadottir R, Prener Holtan J, van den Born LI, Sodi A, Virgili G, Gosheva M, Pach J, Zundorf I, Zrenner E, Gekeler F. Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa: A Multicenter Safety Study of the OkuStim(R) System (TESOLA-Study). Ophthalmic Res. 2020;63(3):234-243. doi: 10.1159/000505001. Epub 2019 Nov 26.