UMIN-CTR Clinical Trial

Basic information
Public title	observation of natural history in retinitis pigmentosa
Acronym	observation of natural history in retinitis pigmentosa
Scientific Title	observation of natural history in retinitis pigmentosa
Scientific Title:Acronym	observation of natural history in retinitis pigmentosa
Region	Japan

Condition
Condition	retinitis pigmentosa
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	to observe natural history of retinitis pigmentosa precisely
Basic objectives2	Others
Basic objectives -Others	observation of natural history
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	progression in visual field defect
Key secondary outcomes	retinal thickness in OCT observation

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients diagnosed as retinitis pigmentosa who agreed to be included in this study
Key exclusion criteria	history of ocular surgeries other than cataract surgery,history of other eye diseases
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hanako O Ikeda
Organization	Kyoto university
Division name	ophthalmology
Zip code
Address	54, Shogoin-Kawaharacho, Kyoto
TEL	0757513727
Email	rpkyoto@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tomoko Hasegawa
Organization	Kyoto university
Division name	ophthalmology
Zip code
Address	54, Shogoin-Kawaharacho, Kyoto
TEL	0757513727
Homepage URL
Email	rpkyoto@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto university, departmentof ophthalomogy
Institute
Department

Funding Source
Organization	Kyoto 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
Address
Tel
Email

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	2016 Year 02 Month 10 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	No longer recruiting
Date of protocol fixation	2016 Year 02 Month 10 Day
Date of IRB	2016 Year 02 Month 12 Day
Anticipated trial start date	2016 Year 03 Month 01 Day
Last follow-up date	2026 Year 02 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	observation of natural history of visual field progression

Management information
Registered date	2016 Year 02 Month 10 Day
Last modified on	2022 Year 02 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024188