UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044475 |
|---|---|
| Receipt number | R000050807 |
| Scientific Title | Prospective Observational Study to Estimate the Genotype and Phenotype of Japanese Patients With X-linked Retinitis Pigmentosa Associated With Pathogenic Variants in Retinitis Pigmentosa GTPase Regulator (RPGR) |
| Date of disclosure of the study information | 2021/06/20 |
| Last modified on | 2024/06/11 12:42:50 |
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Basic information
Public title
An Observational Study of Japanese Participants With X-linked Retinitis Pigmentosa
Acronym
An Observational Study of Japanese Participants With X-linked Retinitis Pigmentosa
Scientific Title
Prospective Observational Study to Estimate the Genotype and Phenotype of Japanese Patients With X-linked Retinitis Pigmentosa Associated With Pathogenic Variants in Retinitis Pigmentosa GTPase Regulator (RPGR)
Scientific Title:Acronym
Prospective Observational Study to Estimate the Genotype and Phenotype of Japanese Patients With X-linked Retinitis Pigmentosa Associated With Pathogenic Variants in Retinitis Pigmentosa GTPase Regulator (RPGR)
Region
| Japan |
Condition
Condition
X-Linked Retinitis Pigmentosa
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of the study is to identify a cohort of Japanese participants with X-linked retinitis pigmentosa (XLRP) associated with pathogenic variants in the retinitis pigmentosa GTPase regulator (RPGR) gene and to investigate their associated phenotype.
Basic objectives2
Others
Basic objectives -Others
The purpose of the study is to identify a cohort of Japanese participants with X-linked retinitis pigmentosa (XLRP) associated with pathogenic variants in the retinitis pigmentosa GTPase regulator (RPGR) gene and to investigate their associated phenotype.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Function
Up to Day 30
Visual function will be assessed using visual acuity.
Retinal Structure
Up to Day 30
Retinal structure will be assessed using spectral domain optical coherence tomography (SDOCT).
Retinal Function
Up to Day 30
Retinal function will be assessed using static visual field testing.
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
| 5 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Have RPGR-associated retinal dystrophy
- Are able to give informed consent or assent, with the guidance of their parent/guardian where appropriate
- Are able to undertake age-appropriate clinical assessments as specified in the protocol
Key exclusion criteria
- Are unable or unwilling to undertake consent or clinical testing
- Participated in another research study and had intraocular surgery within 3 months of screening
- Significant ophthalmologic diseases
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Hirotaka |
| Middle name | |
| Last name | Numaguchi |
Organization
Janssen Pharmaceutical K.K.
Division name
R&D Div. Clinical Science Div. Clinical Development Dept. Medical Group
Zip code
101-0065
Address
3-5-2 Nishikanda, Chiyoda-ku, Tokyo, Japan
TEL
0120-183-275
DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com
Public contact
Name of contact person
| 1st name | Personnel |
| Middle name | |
| Last name | Medical Information Center |
Organization
Janssen Pharmaceutical K.K.
Division name
Medical Information Center
Zip code
101-0065
Address
3-5-2 Nishikanda, Chiyoda-ku, Tokyo, Japan
TEL
0120-183-275
Homepage URL
DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com
Sponsor or person
Institute
Janssen Pharmaceutical K.K.
Institute
Department
Personal name
Funding Source
Organization
Janssen Pharmaceutical K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical Center Ethical Committee
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo, Japan
Tel
03-3411-0111
215-rinri@mail.hosp.go.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
| 2021 | Year | 06 | Month | 20 | 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
| 2020 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 23 | Day |
Date of closure to data entry
| 2024 | Year | 05 | Month | 22 | Day |
Date trial data considered complete
| 2024 | Year | 06 | Month | 18 | Day |
Date analysis concluded
| 2024 | Year | 07 | Month | 19 | Day |
Other
Other related information
An Observational Study of Japanese Participants With X-linked Retinitis Pigmentosa
Management information
Registered date
| 2021 | Year | 06 | Month | 08 | Day |
Last modified on
| 2024 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050807
