UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060789 |
|---|---|
| Receipt number | R000069551 |
| Scientific Title | Differences in Prognosis Based on Timing of Anti-Vascular endothelial growth factor Therapy loading dose in Retinal Vein Occlusion: A Multicenter, Retrospective, Observational Study |
| Date of disclosure of the study information | 2026/03/31 |
| Last modified on | 2026/03/01 17:46:07 |
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Basic information
Public title
Differences in Prognosis Based on Timing of Anti-VEGF Therapy loading dose in Retinal Vein Occlusion: A Multicenter, Retrospective, Observational Study
Acronym
RVO Retrospective Observational Study
Scientific Title
Differences in Prognosis Based on Timing of Anti-Vascular endothelial growth factor Therapy loading dose in Retinal Vein Occlusion: A Multicenter, Retrospective, Observational Study
Scientific Title:Acronym
Anti-VEGF Therapy in Retinal Vascular Occlusion: A Retrospective Observational Study
Region
| Japan |
Condition
Condition
Retinal Vein Occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to establish a multicenter retrospective clinical registry for cases initiating anti-VEGF therapy for macular edema associated with retinal vein occlusion. Using this database, we aim to analyze and evaluate, based on medical records, the impact of the presence or absence of a loading dose on treatment outcomes one year after initiation, thereby contributing to the optimization of RVO treatment in Japan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
One-year visual acuity improvement rate
Key secondary outcomes
Improvement in foveal retinal thickness over one year
Number of treatments over one year
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
1) Patients with retinal vein occlusion (RVO)
2) RVO cases seen since 2020
3) Cases followed for one year
4) Cases aged 20 years or older
Key exclusion criteria
1) Cases under 20 years of age
2) Cases already treated with anti-VEGF agents, laser therapy, or surgery
3) Patients deemed unsuitable as research subjects by the principal investigator or co-investigator
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hidetaka |
| Middle name | |
| Last name | Noma |
Organization
Tokyo Medical University Ibaraki Medical Center
Division name
Ophthalmology
Zip code
300-0395
Address
3-20-1 Chuo, Amimachi, Inashiki-gun, Ibaraki
TEL
0298871611
noma-hide@umin.ac.jp
Public contact
Name of contact person
| 1st name | Hidetaka |
| Middle name | |
| Last name | Noma |
Organization
Tokyo Medical University Ibaraki Medical Center
Division name
Ophthalmology
Zip code
300-0395
Address
3-20-1 Chuo, Amimachi, Inashiki-gun, Ibaraki
TEL
0298871611
Homepage URL
noma-hide@umin.ac.jp
Sponsor or person
Institute
Tokyo Medical University Ibaraki Medical Center
Institute
Department
Personal name
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical University Ibaraki Medical Center
Address
3-20-1 Chuo, Amimachi, Inashiki-gun, Ibaraki
Tel
0298871611
noma-hide@umin.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
| 2026 | Year | 03 | Month | 31 | 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
| 2026 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2026 | 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
In this retrospective study, the clinical information extracted from medical records is as follows:
Age at treatment initiation
Gender
Affected eye (right or left)
RVO type (Major BRVO, macular BRVO, Hemi-RVO, CRVO)
Presence of systemic comorbidities (hypertension, hyperlipidemia, diabetes)
Duration from symptom onset to treatment initiation (weeks)
Visual acuity (at initial visit, at outpatient visit, 1 year later)
Central retinal thickness by OCT (at initial visit, at outpatient visit, 1 year later)
Number of induction-phase sessions
Number of treatment sessions over 1 year
Management information
Registered date
| 2026 | Year | 03 | Month | 01 | Day |
Last modified on
| 2026 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069551
