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TES for the Treatment of RP (TESOLAUK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01847365
Recruitment Status : Completed
First Posted : May 6, 2013
Last Update Posted : November 13, 2018
Sponsor:
Collaborators:
Oxford University Hospitals NHS Trust
Moorfields Eye Hospital NHS Foundation Trust
Information provided by (Responsible Party):
University of Oxford

Study Description
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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.


Condition or disease Intervention/treatment Phase
Retinitis Pigmentosa Device: Transcorneal electrical stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Multicentre Safety Study of the Okustim® System
Study Start Date : April 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Retinitis Pigmentosa
Transcorneal electrical stimulation (TES) administered to one eye for 6 months, followed by monitoring period without treatment for 6 months.
 Device: Transcorneal electrical stimulation
Transcorneal electrical stimulation will be delivered by the CE-marked Okustim device.


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 12 months ]
    Quantity and Character of Adverse Events Related to the Use of the Device


Secondary Outcome Measures :
  1. Efficacy of Intervention [ Time Frame: 12 months ]
    Ophthalmic examination, best corrected visual acuity, visual field assessment, microperimetry, optical coherence tomography, fundus photography


Other Outcome Measures:
  1. Usability of the Device [ Time Frame: 12 months ]
    Non-validated questionnaires


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01847365


Locations
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United Kingdom
Oxford University Hospitals NHS Trust
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Moorfields Eye Hospital NHS Foundation Trust
London, United Kingdom, EC1V 2PD
Sponsors and Collaborators
University of Oxford
Oxford University Hospitals NHS Trust
Moorfields Eye Hospital NHS Foundation Trust
Investigators
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Study Chair: Robert E MacLaren, FRCOphth DPhil University of Oxford, Oxford University Hospitals NHS Trust and Moorfields Eye Hospital NHS Foundation Trust
Principal Investigator: Susan M Downes, FRCOphth MD Oxford University Hospitals NHS Trust and University of Oxford
Principal Investigator: Andrew R Webster, FRCOphth MD UCL Institute of Ophthalmology and Moorfields Eye Hospital NHS Foundation Trust
More Information
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Additional Information:

Publications of Results:

Other Publications:

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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01847365    
Other Study ID Numbers: TESOLAUK13
First Posted: May 6, 2013    Key Record Dates
Last Update Posted: November 13, 2018
Last Verified: November 2018
Keywords provided by University of Oxford:
Retinitis Pigmentosa
Transcorneal electrical stimulation
Okustim
Additional relevant MeSH terms:
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Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
 Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn