UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056284 |
|---|---|
| Receipt number | R000064204 |
| Scientific Title | Investigation of the efficacy of ranibizumab BS and other anti-VEGF drugs for macular edema associated with branch retinal vein occlusion |
| Date of disclosure of the study information | 2024/11/27 |
| Last modified on | 2024/11/27 20:36:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation of the efficacy of ranibizumab BS and other anti-VEGF drugs for macular edema associated with branch retinal vein occlusion
Acronym
Investigation of the efficacy of ranibizumab BS and other anti-VEGF drugs for macular edema associated with branch retinal vein occlusion
Scientific Title
Investigation of the efficacy of ranibizumab BS and other anti-VEGF drugs for macular edema associated with branch retinal vein occlusion
Scientific Title:Acronym
Investigation of the efficacy of ranibizumab BS and other anti-VEGF drugs for macular edema associated with branch retinal vein occlusion
Region
| Japan |
Condition
Condition
Branch retinal vein occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of ranibizumab BS in the treatment of macular edema associated with branch retinal vein occlusion, with resolution of retinal exudate in the early treatment period as the primary endpoint.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change over time in exudative lesions up to 2 months after ranibizumab BS treatment (percentage of dry macula achieved)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were diagnosed with branch retinal vein occlusion and used anti-VEGF agents for the first time among the outpatients of the Department of Ophthalmology, Fukushima Medical University from August 2013 to September 2024.
Key exclusion criteria
1 Patients who have refused the use of their medical information for research
2 Patients who have had subjective symptoms for more than 6 months since the onset of symptoms
3 Patients with diabetic retinopathy in the evaluable eye
4 Patients who have already undergone laser photocoagulation of the evaluable eye prior to the use of anti-VEGF agents
5 Patients who have received subcapsular tenon or intravitreal injections of steroids in the evaluable eye within 60 days prior to the start of anti-VEGF therapy
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Tetsuju |
| Middle name | |
| Last name | Sekiryu |
Organization
Fukushima Medical University
Division name
Department of Ophthalmology
Zip code
9601295
Address
1 Hikarigaoka, Fukushima City, Fukushima Prefecture
TEL
0245471303
sekiryu@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuju |
| Middle name | |
| Last name | Sekiryu |
Organization
Fukushima Medical University
Division name
Department of Ophthalmology
Zip code
9601295
Address
1 Hikarigaoka, Fukushima City, Fukushima Prefecture
TEL
0245471303
Homepage URL
sekiryu@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Senju Pharmaceutical Co.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University, Department of Ophthalmology
Address
1 Hikarigaoka, Fukushima City, Fukushima Prefecture
Tel
0245471303
sekiryu@fmu.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 | 11 | Month | 27 | 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 | 11 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 11 | Month | 27 | Day |
Last modified on
| 2024 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064204
