UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048168 |
|---|---|
| Receipt number | R000049588 |
| Scientific Title | retinal blood flow of retinitis pigmentosa |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2022/06/26 15:55:28 |
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Basic information
Public title
blood flow of optic nerve head and retinal structure of retinitis pigmentosa
Acronym
blood flow of optic nerve head and retinal structure of retinitis pigmentosa
Scientific Title
retinal blood flow of retinitis pigmentosa
Scientific Title:Acronym
retinal blood flow of retinitis pigmentosa
Region
| Japan |
Condition
Condition
retinitis pigmentosa
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Retinitis pigmentosa is an inherited disease caused by degeneration of photoreceptor cells and retinal pigment epithelium.
There is no effective treatment, and cell therapy, artificial retina, and gene therapy are expected to be effective in the future.
Pallor of the optic nerve head is one of the characteristic findings in retinitis pigmentosa, and glial hyperintensities on the optic nerve head have been reported, but the cause of this phenomenon is not clearly understood.
We hypothesize that the cause of the pallor of the optic nerve head may be secondary to photoreceptor degeneration or reduced blood flow. We believe that simultaneous measurement of blood flow in addition to retinal structure will allow us to investigate the cause of the previously unexplained pallor of the optic nerve head in retinitis pigmentosa.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood flow of optic nerve head
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with retinitis pigmentosa who visited our hospital
Key exclusion criteria
Macular epiretinal membrane
Macular edema
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | seiji |
| Middle name | |
| Last name | takagi |
Organization
toho university
Division name
Ophthalmology
Zip code
1438541
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo
TEL
0337624151
naoko.hama@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | naoko |
| Middle name | |
| Last name | hama |
Organization
toho university
Division name
Ophthalmology
Zip code
1438541
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo
TEL
0337624151
Homepage URL
naoko.hama@med.toho-u.ac.jp
Sponsor or person
Institute
toho university
Institute
Department
Personal name
Funding Source
Organization
toho university
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
toho university
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo
Tel
0337624151
naoko.hama@med.toho-u.ac.jp
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
| 2022 | Year | 07 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
no
Management information
Registered date
| 2022 | Year | 06 | Month | 26 | Day |
Last modified on
| 2022 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049588
