UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Voluntary clinical trials to examine the safety and efficacy of transdermal electrical stimulation intended for retinitis pigmentosa
Title of the study (Brief title)	Transdermal electrical stimulation intended for retinitis pigmentosa
Region	Japan

Condition
Condition	Retinitis Pigmentosa
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the safety and efficacy of transdermal electrical stimulation treatment with the skin electrode for retinitis pigmentosa patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Safety (adverse events such as decrease of visual function, skin disorders) Evaluated at the time of 1 hour, 1 week, 2 weeks, and 4 weeks after the end of the treatment
Key secondary outcomes	1:visual acuity 2:Retinal sensitivity 3:electroretinogram 4:Optical coherence tomography 5:Visual field 6:Quality of vision

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Total of three times through the skin electrical stimulation to every two weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who meet all of the following criteria at least one eye 1)typical retinitis pigmentosa patients (less than 20 years of age or 80 years of age) 2)2 times of reliability that was performed within 31 days (fixation failure rate of less than 20%, the false positive rate of less than 15%, false-negative rate of less than 33%) static perimetry (HFA) 10-2 center four points with the average difference in the retina sensitivity is within 3dB, and also less than 30dB any of the value 3)Patient decimal vision of 0.01-0.4 4)Patients with afferent visual field constriction of 10 degrees or less in the 1 / 4 of the Goldman visual field examination (Gp) 5)Patient HFA10-2 of Mean Deviation (MD) value is less than -15dB 6)Patients after receiving a sufficient explanation Upon participation in the present study, after an adequate understanding, the document agreed by the free will of the patient himself was obtained
Key exclusion criteria	Patients conflict with one of the following: 1)Patients with vitreous macular traction syndrome, macular edema, epiretinal membrane, macular lesions such as high myopia with posterior staphyloma 2)Patients undergoing eye surgery within three months 3)Patients who use isopropyl unoprostone, calcium antagonist, dark adaptation improving agent within 31 days 4)Patient with a history of drug allergy for mydriatic, such as eye drops anesthetic that we plan to use during the trial period 5)Patients who are complicated by diabetic retinopathy 6)patients with merging inflammation external eye, infections, or severe dry eye 7)Patients likely to have been pregnant or pregnant. Patients during breast-feeding. Patients who wish to become pregnant during the study period 8)Patients with a history of optic nerve disease 9)Patients with merger moderate (grade3 of Emery classification) or more of nuclear cataract, serious affect such pre subcapsular cataract, posterior subcapsular cataract or secondary cataract in vision
Target sample size	6

Research contact person
Name of lead principal investigator	Takayuki Baba
Organization	Chiba university
Division name	Department of Ophthalmology
Address	1-8-1 Inohana Chuo-ku Chiba-shi Chiba
TEL	043-222-7171
Email	babatakayuki@nifty.com

Public contact
Name of contact person	Gen Miura
Organization	Chiba university
Division name	Department of Ophthalmology
Address	1-8-1 Inohana Chuo-ku Chiba-shi Chiba
TEL	043-222-7171
Homepage URL
Email	gmiura2@chiba-u.jp

Sponsor
Institute	Chiba university Department of Ophthalmology
Institute
Department

Funding Source
Organization	Chiba university Department of Ophthalmology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	UH2016012C
Org. issuing International ID_1	ACReSS
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	千葉大学病院（千葉県）

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 12 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 11 Month 16 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 12 Day
Last modified on	2017 Year 07 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025232