UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056246 |
|---|---|
| Receipt number | R000061649 |
| Scientific Title | Acute retinal necrosis registry study |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2025/01/15 19:32:44 |
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Basic information
Public title
Acute retinal necrosis registry study
Acronym
Acute retinal necrosis registry study
Scientific Title
Acute retinal necrosis registry study
Scientific Title:Acronym
Acute retinal necrosis registry study
Region
| Japan |
Condition
Condition
Acute retinal necrosis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To create clinical practice guidelines
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Route, dose, and duration of antiviral and corticosteroid administration
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who are diagnosed with and treated for acute retinal necrosis in the institutions
Key exclusion criteria
Patients who reject the participation in the research
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Usui |
Organization
Tokyo Medical University
Division name
Ophthalmology
Zip code
160-0023
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
TEL
03-3351-6141
usuyoshi@gmail.com
Public contact
Name of contact person
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Usui |
Organization
Tokyo Medical University
Division name
Ophthalmology
Zip code
160-0023
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
TEL
03-3351-6141
Homepage URL
usuyoshi@gmail.com
Sponsor or person
Institute
Others
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japanese Ocular Inflammation Society
Name of secondary funder(s)
Japanese Ocular Inflammation Society
IRB Contact (For public release)
Organization
Tokyo Medical University, Medical Ethics Review Committee
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
Tel
03-3342-6111
IRB@tokyo-med.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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will be conducted prospectively and retrospectively to observe the findings and the treatments of cases of acute retinal necrosis.
Data will be collected from cooperating institutions in Japan from the initial diagnosis to 3 years later to establish the treatment regimen.
Management information
Registered date
| 2024 | Year | 11 | Month | 22 | Day |
Last modified on
| 2025 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061649
