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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

Tracking Information
First Submitted Date  ICMJE May 1, 2013
First Posted Date  ICMJE May 6, 2013
Last Update Posted Date November 13, 2018
Study Start Date  ICMJE April 2013
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2013)		 Adverse Events [ Time Frame: 12 months ]
Quantity and Character of Adverse Events Related to the Use of the Device
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2013)		 Efficacy of Intervention [ Time Frame: 12 months ]
Ophthalmic examination, best corrected visual acuity, visual field assessment, microperimetry, optical coherence tomography, fundus photography
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 1, 2013)		 Usability of the Device [ Time Frame: 12 months ]
Non-validated questionnaires
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE TES for the Treatment of RP
Official Title  ICMJE Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Multicentre Safety Study of the Okustim® System
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Retinitis Pigmentosa
Intervention  ICMJE Device: Transcorneal electrical stimulation
Transcorneal electrical stimulation will be delivered by the CE-marked Okustim device.
Study Arms  ICMJE Experimental: Retinitis Pigmentosa
Transcorneal electrical stimulation (TES) administered to one eye for 6 months, followed by monitoring period without treatment for 6 months.
Intervention: Device: Transcorneal electrical stimulation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2014)		 14
Original Estimated Enrollment  ICMJE
 (submitted: May 1, 2013)		 12
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01847365
Other Study ID Numbers  ICMJE TESOLAUK13
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Oxford
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Oxford
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Oxford University Hospitals NHS Trust
  • Moorfields Eye Hospital NHS Foundation Trust
Investigators  ICMJE
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
PRS Account University of Oxford
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP