UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory trial to examine the safety and effectiveness of transdermal electrical stimulation for retinitis pigmentosa
Title of the study (Brief title)	Exploratory trial to examine the safety and effectiveness of transdermal electrical stimulation for retinitis pigmentosa
Region	Japan

Condition
Condition	retinitis pigmentosa
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Exploritively verify the safety of transdermal electrical stimulation for retinitis pigmentosa and its effectiveness for visual function after the treatment
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	safety
Key secondary outcomes	effectiveness

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	transdermal electric stimulation
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	A case must satisfying all the following criteria. Evaluation Eye (1) Typical Retinal pigmented patients (over 20 years old and under 80 years old) (2) Static visual field examination (HFA) 10-2 with two reliabilities (less than 20% of fixation defect rate, less than 15% false positive rate, false negative rate less than 33%) executed within 6 months The difference in the average retinal sensitivity at the four central points is within 5 dB and both values are less than 30 dB (3) Patients with decimal visual acuity of 0.1 to 0.7 (4) Patients presenting afferent stenoses within 10 degrees in 1 / 4 of dynamic visual field examination (Gp) (5) Patients with Mean Deviation (MD) value of HFA 10-2 <-10 dB (6) After receiving sufficient explanation for the participation of this trial, patients who gained document consent by the patient's free will with sufficient understanding (7) Patients who can come to hospital for 3 months every 2 weeks
Key exclusion criteria	cases who conflict with any of the following must not include this study. (1) Patients complicated of macular lesions such as vitreous macular traction syndrome, macular edema, epiretinal membrane, and myopia with posterior staphyloma associated with myopia (2) Patients undergoing internal eye surgery within 3 months (3) Patients who changed the dose and usage of isopropyl unoprostone, calcium antagonist, dark adaptation improving drug within 31 days before screening (4) Patients who have a history of drug allergy to drugs to be used during the trial period (mydriatic drugs, eye drops anesthetics, etc.) (5) Patients complicated with diabetic retinopathy (6) Patients who are currently complaining of external eye inflammation, infection, or severe dry eye (7) Patients who may be pregnant or pregnant. Patient who is breastfeeding. Patients who want pregnancy during the trial period (8) Patients with a history of optic nerve disease (9) Evaluation of efficacy nuclear cataract with moderate degree (grade 3 in Emery classification) to the eyes, patients with complication of anterior subcapsular, subcapsular cataract, or late cataract which have a serious effect on vision (10) Patients whose Mean Deviation (MD) value of HFA 10-2 has deteriorated by 3 dB or more per year (11) Patients who have not seen any deterioration in visual acuity, OCT findings, dynamic visual field inspection (Gp) findings, and visual field sensitivities at HFA 10-2 in the last 3 years (12) Patients currently participating in other clinical trials (13) patients under investigational responsibility (shared) doctors judged inappropriate for participation in this trial
Target sample size	10

Research contact person
Name of lead principal investigator	Gen Miura
Organization	Chiba university hospital
Division name	Ophthalmology
Address	1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL	0432227171
Email	gmiura2@chiba-u.jp

Public contact
Name of contact person	Gen Miura
Organization	Chiba university hospital
Division name	Ophthalmology
Address	1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL	0432227171
Homepage URL
Email	gmiura2@chiba-u.jp

Sponsor
Institute	Chiba university hospital
Institute
Department

Funding Source
Organization	Chiba university hospital
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	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 09 Day
Anticipated trial start date	2017 Year 07 Month 18 Day
Last follow-up date	2018 Year 02 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 05 Month 15 Day

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

Management information
Registered date	2017 Year 07 Month 11 Day
Last modified on	2018 Year 12 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031529