Trial document




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  DRKS00023562

Trial Description

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Title

Evaluation of the effectiveness of transcorneal electrostimulation in patients with retinitis pigmentosa - a multicenter, prospective, randomized, controlled and double-blind study on behalf of the G-BA

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Trial Acronym

TES-RP

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URL of the Trial

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Brief Summary in Lay Language

This study, funded by the "Gemeinsamer-Bundesausschuss", will test the efficacy of Transcorneal Electrical Stimulation (TES) in patients with retinitis pigmentosa, a hereditary retinal degeneration. Based on the results, a decision will then be made as to whether TES will be reimbursed by health insurance companies in the future.
The study will last 3 years per patient and each patient will come to the study center for 8 visits. After being instructed in the use of the stimulation device, the patients use the transcorneal electrostimulation at home independently and stimulate once a week for 30 minutes over 3 years.
The study is blinded, which means that neither doctors nor patients know which eye is being stimulated and which eye is the sham treated eye that serves as a control.

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Brief Summary in Scientific Language

"Erprobungsregelung" of the effectiveness of transcorneal electrostimulation in patients with retinitis pigmentosa.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00023562
  •   2021/02/18
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  •   no
  •   Approved
  •   776/2020BO1, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

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Health Condition or Problem studied

  •   Retinitis Pigmentosa
  •   H35.5 -  Hereditary retinal dystrophy
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Interventions/Observational Groups

  •   All patients are treated on one eye, the partner eye is sham treated. Neither the patients nor the physicians know which eye is treated and which eye is sham treated.

    The study eye will be treated with transcorneal electrostimulation once a week for 30 minutes during the study period of 3 years.
    The Okustim device used for this purpose (Okuvision, Reutlingen, Germany) is an already approved medical device. For the stimulation, thin filament electrodes are placed in both eyes on which an initial current pulse is applied to blind which eye is stimulated. Only the study eye is further stimulated afterwards.

  •   All patients are treated on one eye, the partner eye is sham treated. Neither the patients nor the doctors know which eye is treated and which eye is sham treated.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Other
  •   Treatment
  •   Other
  •   IV
  •   N/A
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Primary Outcome

Reduction of area loss in the kinetic visual field (test mark V4e; measured as the difference between baseline and 3-year visit, statistically including all visual field examinations) of the treated eye in relation to the sham-treated eye

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Secondary Outcome

contrast sensitivity,
best corrected visual acuity (BCVA),
static visual field,
color sense,
retinal morphology,
number and severity of adverse events,
vision-related quality of life

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Doctor's Practice 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Planned
  •   2021/05/02
  •   154
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

1. patients with syndromal or non-syndromal RP (autosomal dominant, auto-somal recessive and X-linked)
2. adults of all sexes aged 18 - 80 years
3. BCVA (ETDRS visual acuity) between 0.1 and 0.8 in both eyes with no more than 15 ETDRS letters (3 lines) difference between eyes
4. octopus 900, kinetic visual field
a. Visual field area equal to or greater than 75 deg2 (corresponding to an average radius of 5 degrees; stimulus V4e) in both eyes.
b. The difference between the two eyes must have a ratio "OD/OS" not less than 0.5 and not more than 2
5. able and willing to give written informed consent for the study

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Exclusion Criteria

Ophthalmic exclusion criteria:
1. optic neuritis / optical neuropathy.
2. diabetic retinopathy
3. neovascularization of the retina of different genesis
4. condition after retinal artery or vein occlusion
5. condition after retinal detachment or vitreoretinal surgery
6. silicone oil tamponade
7. dry or neovascular AMD
8. macular edema (SD-OCT)
9. glaucoma
10. corneal degeneration affecting visual acuity
11. opacity of refractive media affecting OCT/FP/ophthalmoscopy (lens classification).
12. cataract which, in the opinion of the investigator, may require surgery during the study period
13. aphakia
14. TES therapy in the last 3 months

Further exclusion criteria
15. any chronic, non-controllable or unmanaged disease, e.g., but not limited to, cardiac or pulmonary disease, which increases the patient's risk during study participation
16. poor general health that, in the opinion of the investigator, makes it difficult for the patient to reliably participate in visit appointments or to complete therapy
17. mental illnesses such as bipolar disorder, schizo-affective disorder, addictions or dementia
18. neurological diseases such as epilepsy or Parkinson's disease, which may pose a problem for the application of the therapy
19. concurrent participation in other intervention studies or history of study participation, the effects of which may be ongoing
20. active implants (except cochlear implants in a deactivated state)
21. pregnancy or childbearing women of childbearing potential or lactation
22. basic concerns of the investigator that the patient is capable and fit to participate.
23. allergies to the materials used in the TES.

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Addresses

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    • Universitätsklinikum Tübingen
    • Geissweg 3
    • 72076  Tübingen
    • Germany
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    • Department für Augenheilkunde, Universitätsklinikum Tübingen
    • Mr.  Dr.  Tobias  Peters 
    • Elfriede-Aulhorn-Straße 7
    • 72076  Tübingen
    • Germany
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    • Department für Augenheilkunde, Universitätsklinikum Tübingen
    • Ms.  Dr.  Nadine  Kahle 
    • Elfriede-Aulhorn-Straße 7
    • 72076  Tübingen
    • Germany
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Sources of Monetary or Material Support

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    • Gemeinsamer Bundesausschuss
    • Gutenbergstraße 13
    • 10587  Berlin
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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