UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057025 |
|---|---|
| Receipt number | R000065178 |
| Scientific Title | Prospective observational study of the natural history of patients with retinitis pigmentosa: the KEYS study |
| Date of disclosure of the study information | 2025/02/28 |
| Last modified on | 2026/04/23 16:34:30 |
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Basic information
Public title
Prospective observational study of the natural history of patients with retinitis pigmentosa: the KEYS study
Acronym
Prospective observational study of the natural history of patients with retinitis pigmentosa: the KEYS study
Scientific Title
Prospective observational study of the natural history of patients with retinitis pigmentosa: the KEYS study
Scientific Title:Acronym
Prospective observational study of the natural history of patients with retinitis pigmentosa: the KEYS study
Region
| Japan |
Condition
Condition
Retinitis pigmentosa
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To observe the natural history of visual fields and other parameters in patients with retinitis pigmentosa and to consider the endpoints and evaluation period for future therapeutic intervention for retinitis pigmentosa.
Basic objectives2
Others
Basic objectives -Others
Natural history of visual fields and other parameters in patients with retinitis pigmentosa
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual function (Corrected visual acuity, Visual field, etc.)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have been diagnosed with retinitis pigmentosa in both eyes
Key exclusion criteria
Any decision by the Investigator to terminate a subject in screening
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Togashi |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
Ophthalmology Innovation Center
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9339
translational.research@santen.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Togashi |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
Ophthalmology Innovation Center
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9339
Homepage URL
translational.research@santen.com
Sponsor or person
Institute
Santen Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Santen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Santen Pharmaceutical Co., Ltd.
Address
4-20, Ofukacho, Kita-ku, Osaka
Tel
06-4802-9339
translational.research@santen.com
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
地方独立行政法人神戸市民病院機構 神戸市立神戸アイセンター病院（兵庫県）
Kobe City Eye Hospital (Hyogo)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 28 | Day |
Related information
URL releasing protocol
https://iovs.arvojournals.org/article.aspx?articleid=2806887
Publication of results
Published
Result
URL related to results and publications
https://iovs.arvojournals.org/article.aspx?articleid=2806887
Number of participants that the trial has enrolled
49
Results
This study examined disease progression in EYS-associated retinitis pigmentosa over two years. At baseline, visual acuity was 0.12+/-0.28 logMAR, HFA-MD was -16.9+/-8.4 dB, and EZ width was 2093+/-1829 um. Over two years, EZ width declined significantly and correlated moderately with HFA-MD, but no significant changes were seen in visual acuity or HFA-MD.
(Invest. Ophthalmol. Vis. Sci.. 2025; 66(8):3164.)
Results date posted
| 2025 | Year | 07 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
EYS-associated retinitis pigmentosa (EYS-RP)
Participant flow
In this study, patients with EYS-RP who met the eligibility criteria were enrolled and prospectively observed for two years.
Adverse events
None
Outcome measures
Visual acuity, Visual field, Ellipsoid zone width
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Through this clinical research to observe the natural history of the visual field and other parameters of the disease in patients with retinitis pigmentosa, it is expected to establish endpoints and evaluation periods for future therapeutic interventions for retinitis pigmentosa.
Management information
Registered date
| 2025 | Year | 02 | Month | 14 | Day |
Last modified on
| 2026 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065178
