UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057843 |
|---|---|
| Receipt number | R000066123 |
| Scientific Title | Effect of anti-VEGF therapy on microaneurysms in macula edema associated with retinal vein occulusion |
| Date of disclosure of the study information | 2025/05/19 |
| Last modified on | 2025/05/12 21:31:50 |
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Basic information
Public title
Effect of anti-VEGF therapy on microaneurysms in macula edema associated with retinal vein occulusion
Acronym
Effect of anti-VEGF therapy on microaneurysms in macula edema associated with retinal vein occulusion
Scientific Title
Effect of anti-VEGF therapy on microaneurysms in macula edema associated with retinal vein occulusion
Scientific Title:Acronym
Effect of anti-VEGF therapy on microaneurysms in macula edema associated with retinal vein occulusion
Region
| Japan |
Condition
Condition
macula edema associated with retinal vein occulusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the efficacy of anti-VEGF therapy for microaneurysms associated with macular edema secondary to retinal vein occlusion
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the number of microaneurysms in fluorescein angiography and optical coherence tomography angiography before and after faricimab 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who received faricimab for retinal vein occlusion with macular edema at the Department of Ophthalmology, Fukui University Hospital and its collaborative research institutes between April 1, 2024 and March 31, 2026
Key exclusion criteria
Patients who refused to be enrolled in this study.
Patients who were unable to undergo ophthalmologic examination due to cognitive or physical factors.
Other cases in which the principal investigator determines that the patient is inappropriate as a research subject.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Yamada |
Organization
university of Fukui Hospital
Division name
Ophthalmology
Zip code
9101193
Address
23-3, matcuoka shimoaituki, eiheiji-cho, yoshida-gun, Fukui
TEL
0776-61-8403
yyutaka@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Yamada |
Organization
university of Fukui Hospital
Division name
Ophthalmology
Zip code
9101193
Address
23-3, matcuoka shimoaituki, eiheiji-cho, yoshida-gun, Fukui
TEL
0776-61-8403
Homepage URL
yyutaka@u-fukui.ac.jp
Sponsor or person
Institute
university of Fukui Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Medical University Ibaraki Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
university of Fukui Hospital
Address
23-3, matcuoka shimoaituki, eiheiji-cho, yoshida-gun, Fukui
Tel
0776-61-8403
yyutaka@u-fukui.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 | 05 | Month | 19 | 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
| 2024 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing particular
Management information
Registered date
| 2025 | Year | 05 | Month | 12 | Day |
Last modified on
| 2025 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066123
