UMIN-CTR Clinical Trial

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
Email	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
Email	naoko.hama@med.toho-u.ac.jp

Sponsor
Institute	toho university
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049588