NCT01847365

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 1, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

November 13, 2018

Status Verified

November 1, 2018

Enrollment Period

1.8 years

First QC Date

May 1, 2013

Last Update Submit

November 8, 2018

Conditions

Retinitis Pigmentosa

Keywords

Retinitis PigmentosaTranscorneal electrical stimulationOkustim

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

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

    12 months

Secondary Outcomes (1)

  • Efficacy of Intervention

    12 months

Other Outcomes (1)

  • Usability of the Device

    12 months

Study Arms (1)

Retinitis Pigmentosa

EXPERIMENTAL

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

Device: Transcorneal electrical stimulation

Interventions

Transcorneal electrical stimulationDEVICE

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

Retinitis Pigmentosa

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oxford University Hospitals NHS Trust

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Moorfields Eye Hospital NHS Foundation Trust

London, EC1V 2PD, United Kingdom

Location

Related 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. doi: 10.1167/tvst.5.6.10. eCollection 2016 Dec.

    PMID: 27933220BACKGROUND

  • 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.

    PMID: 29354722RESULT

Related Links

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Robert E MacLaren, FRCOphth DPhil

    University of Oxford, Oxford University Hospitals NHS Trust and Moorfields Eye Hospital NHS Foundation Trust

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2013

First Posted

May 6, 2013

Study Start

April 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

November 13, 2018

Record last verified: 2018-11

Locations

GB(2)