UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028190 |
|---|---|
| Receipt number | R000031529 |
| Scientific Title | Exploratory trial to examine the safety and effectiveness of transdermal electrical stimulation for retinitis pigmentosa |
| Date of disclosure of the study information | 2017/07/12 |
| Last modified on | 2018/12/01 12:47:20 |
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Basic information
Public title
Exploratory trial to examine the safety and effectiveness of transdermal electrical stimulation for retinitis pigmentosa
Acronym
Exploratory trial to examine the safety and effectiveness of transdermal electrical stimulation for retinitis pigmentosa
Scientific Title
Exploratory trial to examine the safety and effectiveness of transdermal electrical stimulation for retinitis pigmentosa
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Gen Miura |
Organization
Chiba university hospital
Division name
Ophthalmology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
0432227171
gmiura2@chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Gen Miura |
Organization
Chiba university hospital
Division name
Ophthalmology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
0432227171
Homepage URL
gmiura2@chiba-u.jp
Sponsor or person
Institute
Chiba university hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 09 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031529
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