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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

Organizational Data

DRKS-ID:
DRKS00023562
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2021-02-18
Last update in DRKS:
2022-07-21
Registration type:
Prospective

Acronym/abbreviation of the study

TES-RP

URL of the study

No Entry

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.

Brief summary in scientific language

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

Health condition or problem studied

Free text:
MedDRA - Retinitis Pigmentosa
ICD10:
H35.5 - Hereditary retinal dystrophy
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
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.
Arm 2:
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.

Endpoints

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
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

Study Design

Purpose:
Treatment
Allocation:
Randomized controlled study
Control:
  • Other
Phase:
IV
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
Yes
Assignment:
Other
Sequence generation:
No Entry
Who is blinded:
  • Investigator/therapist
  • Patient/subject

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Aachen
  • University medical center Bonn
  • University medical center Würzburg
  • University medical center Tübingen
  • Doctor's practice Berlin
  • University medical center Kiel
  • University medical center Heidelberg
  • University medical center Freiburg
  • Medical center Charité Berlin
  • University medical center München
  • University medical center Leipzig
  • University medical center Köln
  • Medical center Sulzbach
  • University medical center Frankfurt a.M.
  • Medical center Stuttgart

Recruitment period and number of participants

Planned study start date:
2021-05-02
Actual study start date:
2021-05-02
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
134
Final Sample Size:
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Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
80 Years
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

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.

Addresses

Primary Sponsor

Universitätsklinikum Tübingen
Geissweg 3
72076 Tübingen
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.medizin.uni-tuebingen.de
Investigator Sponsored/Initiated Trial (IST/IIT):
No

Contact for Scientific Queries

Department für Augenheilkunde, Universitätsklinikum Tübingen
Dr. Tobias Peters
Elfriede-Aulhorn-Straße 7
72076 Tübingen
Germany
Telephone:
+49 7071 29 84894
Fax:
+49 7071 29 5021
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Department für Augenheilkunde, Universitätsklinikum Tübingen
Dr. Nadine Kahle
Elfriede-Aulhorn-Straße 7
72076 Tübingen
Germany
Telephone:
+49 7071 29 84920
Fax:
+49 7071 29 5021
Contact per E-Mail
URL:
No Entry

Principal Investigator

Department für Augenheilkunde, Universitätsklinikum Tübingen
Dr. Tobias Peters
Elfriede-Aulhorn-Straße 7
72076 Tübingen
Germany
Telephone:
+49 7071 29 84894
Fax:
+49 7071 29 5021
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Gemeinsamer Bundesausschuss
Gutenbergstraße 13
10587 Berlin
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2020-09-18
Ethics committee number:
776/2020BO1
Vote of the Ethics Committee:
Approved
Date of the vote:
2020-10-21

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
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Publication of study results

Planned publication:
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Publikationen/Studienergebnisse:
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Date of first publication of study results:
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DRKS entry published for the first time with results:
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Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry