UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000921 |
|---|---|
| Receipt number | R000001106 |
| Scientific Title | Effects of steroid and bevacizumab in retinal vascular diseases |
| Date of disclosure of the study information | 2007/12/03 |
| Last modified on | 2021/03/23 15:39:43 |
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Basic information
Public title
Effects of steroid and bevacizumab in retinal vascular diseases
Acronym
Effects of steroid and bevacizumab
Scientific Title
Effects of steroid and bevacizumab in retinal vascular diseases
Scientific Title:Acronym
Effects of steroid and bevacizumab
Region
| Japan |
Condition
Condition
retinal vascular diseases (diabetic retinopathy, retinal vein occulusion, age-related maculopathy)
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of steroid and/or anti-VEGF antibody in the treatment of retinal vascular diseases
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
examination of fundus findings by ophthalmoloscope, visual acuity, retinal thickness, other general ophthalolmological examinations
Key secondary outcomes
Ophthalmological complications including ocular hypertension, ocular circulation diseases), and systemic complications (hypertension)
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
subjects with retinal vascular diseases
Key exclusion criteria
subjects with systemic risk factors of macrovascular diseases)
subjects with risk factors for ophthalmological surgeries
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidetoshi Yamashita |
Organization
Yamagata University Hospital
Division name
Department of Ophthalmology
Zip code
Address
Iidanishi 2-2-2, Yamagata
TEL
023-628-5374
hyama-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sakiko Goto |
Organization
Yamagata University Hospital
Division name
Ophthalmology
Zip code
Address
Iidanishi 2-2-2, Yamagata
TEL
023-628-5374
Homepage URL
nakano-ygt@umin.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Yamagata University
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology and Visual Science, Yamagata University Faculty of Medicine
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
Address
Tel
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
| 2007 | Year | 12 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Terminated
Date of protocol fixation
| 2007 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2007 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2007 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The tentative results concerning the effects of steroid (triamcinolone), bevacizumab, and both are analyzed, and we are planning to present the data in the ophthalomogical congress.
Management information
Registered date
| 2007 | Year | 12 | Month | 02 | Day |
Last modified on
| 2021 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001106
