UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021887
Receipt number R000025232
Scientific Title Voluntary clinical trials to examine the safety and efficacy of transdermal electrical stimulation intended for retinitis pigmentosa
Date of disclosure of the study information 2016/04/12
Last modified on 2017/07/11 22:06:18

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Basic information

Public title

Voluntary clinical trials to examine the safety and efficacy of transdermal electrical stimulation intended for retinitis pigmentosa

Acronym

Transdermal electrical stimulation intended for retinitis pigmentosa

Scientific Title

Voluntary clinical trials to examine the safety and efficacy of transdermal electrical stimulation intended for retinitis pigmentosa

Scientific Title:Acronym

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

1st name
Middle name
Last name Takayuki Baba

Organization

Chiba university

Division name

Department of Ophthalmology

Zip code


Address

1-8-1 Inohana Chuo-ku Chiba-shi Chiba

TEL

043-222-7171

Email

babatakayuki@nifty.com


Public contact

Name of contact person

1st name
Middle name
Last name Gen Miura

Organization

Chiba university

Division name

Department of Ophthalmology

Zip code


Address

1-8-1 Inohana Chuo-ku Chiba-shi Chiba

TEL

043-222-7171

Homepage URL


Email

gmiura2@chiba-u.jp


Sponsor or person

Institute

Chiba university
Department of Ophthalmology

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2015 Year 11 Month 16 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025232


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name