TES for the Treatment of RP

Retinitis Pigmentosa Clinical Trial

— TESOLAUK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01847365
• Other study ID #: TESOLAUK13
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: February 2015

Study information

• Verified date: November 2018
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Retinitis pigmentosa (RP) is a progressive degenerative disease of the retina, which often leads to blindness. 1 in 4000 people in the UK are affected by RP yet there is no established therapy for treating or delaying its progression.

Transcorneal electrical stimulation (TES) has garnered attention as a possible therapeutic option for RP. Research has shown that TES improves retinal cell viability and visual function. An initial pilot study of TES on 24 participants with RP demonstrated that it was safe and improved vision.

This study aims to confirm the safety of the new CE-approved Okustim device and to further characterise the benefits of TES on a larger scale. 12 participants will be enrolled for 1 year across two sites in the UK - the Oxford Eye Hospital and London Moorfields Eye Hospital.

Recruited participants will undergo weekly TES of 1 eye for 30 minutes for a period of 6 months. This will be followed by a further 6 months of observation without stimulation giving a total participation time of 1 year. Participants will be assessed at 3, 6, 9 and 12 months after their initial baseline visit by clinical examination, investigations and questionnaires.

Participants should have a diagnosis of RP and be capable of giving consent. Participants, or a carer, should have sufficient motor skills to attach the device themselves. As this study seeks to ascertain the impact of TES on RP, participants with other eye diseases (e.g. diabetic retinopathy) cannot be included in the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participant is willing and able to give informed consent for participation in the study

• Male or Female, 18 or more years of age

• Diagnosis of retinitis pigmentosa (rod-cone dystrophy) made by an ophthalmologist

• Participants should have a visual acuity of = 0.02 (Snellen Chart)

• Able (in the investigators opinion) and willing to comply with all study requirements

• Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study

• Participants, or a designated other, should have sufficient motor skills (assessed by the investigator) to apply the device independently

Exclusion Criteria:

• Female participants who are pregnant, lactating or planning pregnancy during the course of the study

• Diabetic Retinopathy

• Previous arterial or venous occlusion of the retina

• Previous retinal detachment

• Previous silicone oil tamponade

• Dry or exudative age-related macular degeneration

• Macular oedema

• All forms of glaucoma

• Any form of corneal degeneration that reduces visual acuity

• Neovascularisation of any origin

• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study

• Forms of mental illness related to bipolar affective and schizoid-affective disorders, and all forms of dementia

• Simultaneous participation in another interventional study or history of interventions where effects may still persist

Related Conditions & MeSH terms

• Retinitis
• Retinitis Pigmentosa

Intervention

Device:
• Transcorneal electrical stimulation
Transcorneal electrical stimulation will be delivered by the CE-marked Okustim device.

Locations

Country	Name	City	State
United Kingdom	Moorfields Eye Hospital NHS Foundation Trust	London
United Kingdom	Oxford University Hospitals NHS Trust	Oxford	Oxfordshire

Sponsors (3)

Lead Sponsor	Collaborator
University of Oxford	Moorfields Eye Hospital NHS Foundation Trust, Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Jolly JK, Wagner SK, Moules J, Gekeler F, Webster AR, Downes SM, MacLaren RE. A Novel Method for Quantitative Serial Autofluorescence Analysis in Retinitis Pigmentosa Using Image Characteristics. Transl Vis Sci Technol. 2016 Dec 1;5(6):10. eCollection 2016 Dec. — View Citation

Wagner SK, Jolly JK, Pefkianaki M, Gekeler F, Webster AR, Downes SM, Maclaren RE. Transcorneal electrical stimulation for the treatment of retinitis pigmentosa: results from the TESOLAUK trial. BMJ Open Ophthalmol. 2017 Dec 14;2(1):e000096. doi: 10.1136/b — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Usability of the Device	Non-validated questionnaires	12 months
Primary	Adverse Events	Quantity and Character of Adverse Events Related to the Use of the Device	12 months
Secondary	Efficacy of Intervention	Ophthalmic examination, best corrected visual acuity, visual field assessment, microperimetry, optical coherence tomography, fundus photography	12 months

External Links

•   Oxford Eye Hospital