UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059005 |
|---|---|
| Receipt number | R000067484 |
| Scientific Title | Observational Study of the Natural History of Retinal Degenerative Diseases |
| Date of disclosure of the study information | 2026/01/01 |
| Last modified on | 2025/09/05 14:22:52 |
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Basic information
Public title
Observational Study of the Natural History of Retinal Degenerative Diseases
Acronym
Observational Study of Retinal Degenerative Diseases
Scientific Title
Observational Study of the Natural History of Retinal Degenerative Diseases
Scientific Title:Acronym
Observational Study of Retinal Degenerative Diseases
Region
| Japan |
Condition
Condition
Retinal Degenerative Diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to visualize the degenerative process of the retina in retinal degenerative diseases, including hereditary retinal degenerative diseases, from multiple perspectives and to elucidate their natural course. By combining imaging diagnostic techniques and functional assessments, we aim to clarify the progression of the disease state that cannot be fully captured by conventional visual field tests and visual acuity tests alone.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Retinal structure (retinal thickness, morphology of each layer) as determined by OCT (optical coherence tomography) examination
Key secondary outcomes
Visual field, electroretinogram, fundus fluorescein angiography, fundus autofluorescence imaging, retinal and optic nerve blood flow, corneal findings, visual acuity, subjective symptoms, treatment methods, complications
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
| 1 | years-old | <= |
Age-upper limit
| 130 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with retinal degenerative diseases undergoing outpatient treatment at Osaka Medical and Pharmaceutical University Hospital. Diagnosis of retinitis pigmentosa and related disorders follows the Retinitis Pigmentosa Diagnosis and Treatment Guidelines.
2) Patients with retinal degenerative diseases who have previously visited this hospital since 2015.
3) No age restrictions apply.
Key exclusion criteria
None
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hanako |
| Middle name | Ohashi |
| Last name | Ikeda |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Ophthalmology
Zip code
569-8686
Address
Diagaku-cho 2-7, Takatsuki-shi
TEL
81726831221
hanako.ikeda@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Hanako |
| Middle name | Ohashi |
| Last name | Ikeda |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Ophthalmology
Zip code
569-8686
Address
2-7 Daigaku-cho, Takatsuki-shi
TEL
81726831221
Homepage URL
hanako.ikeda@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical and Pharmaceutical University
Address
2-7 Daigaku-cho, Takatsuki-shi
Tel
81726831221
hanako.ikeda@ompu.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
大阪府
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Analyze the characteristics of retinal structure, visual field, and fundus photographs for each patient, along with correlations among the respective test values. Analyze the changes in each test value over time.
Management information
Registered date
| 2025 | Year | 09 | Month | 05 | Day |
Last modified on
| 2025 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067484
