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TES for the Treatment of RP (TESOLAUK)

Primary Purpose

Retinitis Pigmentosa

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Transcorneal electrical stimulation
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinitis Pigmentosa focused on measuring Retinitis Pigmentosa, Transcorneal electrical stimulation, Okustim

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Oxford University Hospitals NHS Trust
  • Moorfields Eye Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Retinitis Pigmentosa

Arm Description

Transcorneal electrical stimulation (TES) administered to one eye for 6 months, followed by monitoring period without treatment for 6 months.

Outcomes

Primary Outcome Measures

Adverse Events
Quantity and Character of Adverse Events Related to the Use of the Device

Secondary Outcome Measures

Efficacy of Intervention
Ophthalmic examination, best corrected visual acuity, visual field assessment, microperimetry, optical coherence tomography, fundus photography

Full Information

First Posted
May 1, 2013
Last Updated
November 8, 2018
Sponsor
University of Oxford
Collaborators
Oxford University Hospitals NHS Trust, Moorfields Eye Hospital NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01847365
Brief Title
TES for the Treatment of RP
Acronym
TESOLAUK
Official Title
Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Multicentre Safety Study of the Okustim® System
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
Oxford University Hospitals NHS Trust, Moorfields Eye Hospital NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinitis Pigmentosa
Keywords
Retinitis Pigmentosa, Transcorneal electrical stimulation, Okustim

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Retinitis Pigmentosa
Arm Type
Experimental
Arm Description
Transcorneal electrical stimulation (TES) administered to one eye for 6 months, followed by monitoring period without treatment for 6 months.
Intervention Type
Device
Intervention Name(s)
Transcorneal electrical stimulation
Intervention Description
Transcorneal electrical stimulation will be delivered by the CE-marked Okustim device.
Primary Outcome Measure Information:
Title
Adverse Events
Description
Quantity and Character of Adverse Events Related to the Use of the Device
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Efficacy of Intervention
Description
Ophthalmic examination, best corrected visual acuity, visual field assessment, microperimetry, optical coherence tomography, fundus photography
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Usability of the Device
Description
Non-validated questionnaires
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert E MacLaren, FRCOphth DPhil
Organizational Affiliation
University of Oxford, Oxford University Hospitals NHS Trust and Moorfields Eye Hospital NHS Foundation Trust
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Susan M Downes, FRCOphth MD
Organizational Affiliation
Oxford University Hospitals NHS Trust and University of Oxford
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew R Webster, FRCOphth MD
Organizational Affiliation
UCL Institute of Ophthalmology and Moorfields Eye Hospital NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oxford University Hospitals NHS Trust
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Moorfields Eye Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27933220
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.
Results Reference
background
PubMed Identifier
29354722
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.
Results Reference
result
Links:
URL
http://www.eye.ox.ac.uk
Description
Oxford Eye Hospital

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TES for the Treatment of RP

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