UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046423 |
|---|---|
| Receipt number | R000052972 |
| Scientific Title | A multicenter study aiming to create evidence for clinical biomarkers in autoimmune retinopathy |
| Date of disclosure of the study information | 2022/01/01 |
| Last modified on | 2024/06/25 16:27:55 |
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Basic information
Public title
A multicenter study aiming to create evidence for clinical biomarkers in autoimmune retinopathy
Acronym
Clinical biomarkers in autoimmune retinopathy
Scientific Title
A multicenter study aiming to create evidence for clinical biomarkers in autoimmune retinopathy
Scientific Title:Acronym
Clinical biomarkers in autoimmune retinopathy
Region
| Japan |
Condition
Condition
autoimmune retinopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To disclose clinical biomarkers in autoimmune retinopathy
Basic objectives2
Others
Basic objectives -Others
To disclose change in visual acuity in patients with autoimmune retinopathy in real-world clinical practice
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
change in best-corrected visual acuity improvement from baseline to 6 months
Key secondary outcomes
the following parameters during 6-month follow-up:
(1) change in visual field from baseline to 6 months
(2) change in optical coherence tomography findings
(3) change in comprehenisive protein array data from blood samples
(4) change in metabolome profile from blood samples
(5) difference in comprehenisive protein array data from blood samples between patinets with autoimmune retinopathy and healthy volunteers
(6) difference in metabolome profile from blood samples between patinets with autoimmune retinopathy and healthy volunteers
(7) adverse events
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
[Patinet with autoimmune retinopathy]
Patinet who meets all of the following:
(1) sudden-onset visual disorder
(2) no cause of visual disorder is specified in a routine clinical examination
(3) abnotmal electroretinogram
(4) absence of fundus findings and retnal degeneration/retinal distrophy which can explain visual disorder
(5) absence of apparent ocular inflamation
(6) presence of outer retinal abnormality on optical coherence tomography (OCT)
[Healthy volunteer]
Healthy adult who shows no ocular abnormality except for mild cataract
Key exclusion criteria
[Patinet with autoimmune retinopathy]
(1) uveitis with specific cause
(2) inherited retinal diseases
(3) optic nerve disorders
(4) opacification in anterior segment of the eye and/or optic media which precludes fundus assessment
(5) drug-induced retinal disorders
(6) aged younger than 20 years
(7) patinet who disagrees with this study
(8) patinet who the attending doctor judges as ineligibile to participate in this study
[Healthy volunteer]
Individual who disagrees with this study
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Sentaro |
| Middle name | |
| Last name | Kusuhara |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Ophthalmology, Department of Surgery
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-6048
kusu@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Sentaro |
| Middle name | |
| Last name | Kusuhara |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Ophthalmology, Department of Surgery
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-6048
Homepage URL
kusu@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development: AMED
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yamaguchi University
Osaka University
Yamagata University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee at Kobe University Graduate School of Medicine
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
Tel
078-382-6669
kansatsu@med.kobe-u.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
| 2022 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 07 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 12 | Month | 21 | Day |
Last modified on
| 2024 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052972
