Unique ID issued by UMIN | UMIN000044475 |
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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 | 2022/12/12 15:29:36 |
An Observational Study of Japanese Participants With X-linked Retinitis Pigmentosa
An Observational Study of Japanese Participants With X-linked Retinitis Pigmentosa
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)
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)
Japan |
X-Linked Retinitis Pigmentosa
Ophthalmology |
Others
YES
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.
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.
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.
Observational
5 | years-old | <= |
Not applicable |
Male and Female
- 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
- 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
15
1st name | Hirotaka |
Middle name | |
Last name | Numaguchi |
Janssen Pharmaceutical K.K.
R&D Div. Clinical Science Div. Clinical Development Dept. Medical Group
101-0065
3-5-2 Nishikanda, Chiyoda-ku, Tokyo, Japan
0120-183-275
DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com
1st name | Personnel |
Middle name | |
Last name | Medical Information Center |
Janssen Pharmaceutical K.K.
Medical Information Center
101-0065
3-5-2 Nishikanda, Chiyoda-ku, Tokyo, Japan
0120-183-275
DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com
Janssen Pharmaceutical K.K.
Janssen Pharmaceutical K.K.
Profit organization
Tokyo Medical Center Ethical Committee
2-5-1 Higashigaoka, Meguro-ku, Tokyo, Japan
03-3411-0111
215-rinri@mail.hosp.go.jp
NO
2021 | Year | 06 | Month | 20 | Day |
Unpublished
No longer recruiting
2020 | Year | 09 | Month | 10 | Day |
2021 | Year | 03 | Month | 26 | Day |
2021 | Year | 07 | Month | 30 | Day |
2023 | Year | 08 | Month | 03 | Day |
An Observational Study of Japanese Participants With X-linked Retinitis Pigmentosa
2021 | Year | 06 | Month | 08 | Day |
2022 | Year | 12 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050807
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