Clinical trial NCT01847365: TES for the Treatment of RP
Official title: Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Multicentre Safety Study of the Okustim® System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinitis Pigmentosa
Keywords: Retinitis Pigmentosa
Transcorneal electrical stimulation
Okustim
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Oxford University Hospitals NHS Trust
name: Moorfields Eye Hospital NHS Foundation Trust
First posted: 2013-05-06
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Adverse Events
timeFrame: 12 months
Secondary outcomes:
measure: Efficacy of Intervention
timeFrame: 12 months
Other outcomes:
measure: Usability of the Device
timeFrame: 12 months
Locations:
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Trust
state: Oxfordshire
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust
Study officials:
affiliation: University of Oxford, Oxford University Hospitals NHS Trust and Moorfields Eye Hospital NHS Foundation Trust
name: Robert E MacLaren, FRCOphth DPhil
role: STUDY_CHAIR
affiliation: Oxford University Hospitals NHS Trust and University of Oxford
name: Susan M Downes, FRCOphth MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCL Institute of Ophthalmology and Moorfields Eye Hospital NHS Foundation Trust
name: Andrew R Webster, FRCOphth MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1167/tvst.5.6.10. eCollection 2016 Dec.
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/bmjophth-2017-000096. eCollection 2017.