UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058560 |
|---|---|
| Receipt number | R000066794 |
| Scientific Title | Association between Aqueous Humor Components and Retinal Diseases |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/07/23 12:58:08 |
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Basic information
Public title
Association between Aqueous Humor Components and Retinal Diseases
Acronym
Association between Aqueous Humor Components and Retinal Diseases
Scientific Title
Association between Aqueous Humor Components and Retinal Diseases
Scientific Title:Acronym
Association between Aqueous Humor Components and Retinal Diseases
Region
| Japan |
Condition
Condition
Retinal disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Anti-VEGF injection is the treatment for some of Retinal disease(Age-related macula degeneration, Diabetic macular edema, and others).In this treatment, the anterior chamber paracentesis prevent patients from ocular hypertation.
Althogh aqueous humor is usually discarded, we collect it to perform component analysis, such as VEGF concentration, to assess the prognostic implications for various retinal diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of the aqueous humor components
Key secondary outcomes
Sex, Age, Family history, Past in history,Diagnosis, Complications, visual acuity, Intraocular pressure, Slit beam examination, Funduscopy,optical coherence tomography
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients requiring anti-VEGF treatment who have given informed consent to participate in the research.
Key exclusion criteria
Patients with contraindications to the anti-VEGF treatment or anterior chamber paracentesis.(for example, intraocular infection)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ueno |
| Middle name | |
| Last name | Shinji |
Organization
Hirosaki University
Division name
Ophthalmology
Zip code
036-8562
Address
Zaifu 5, Hirosaki city, Aomori prefecture
TEL
0172-39-5095
retina@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Ueno |
| Middle name | |
| Last name | Shinji |
Organization
Hirosaki University
Division name
Ophthalmology
Zip code
036-8562
Address
Zaifu 5, Hirosaki city, Aomori prefecture
TEL
0172-39-5095
Homepage URL
retina@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Hirosaki University
Address
Zaifu 5, Hirosaki city, Aomori prefecture
Tel
0172-33-5111
rinri@hirosaki-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
| 2025 | Year | 08 | 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 | 07 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 07 | Month | 23 | Day |
Last modified on
| 2025 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066794
