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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000000921
Receipt No. 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 2015/06/02

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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
Email 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
Email nakano-ygt@umin.ac.jp

Sponsor
Institute Department of Ophthalmology, Yamagata University
Institute
Department

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
Email

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 Suspended
Date of protocol fixation
2007 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 04 Month 01 Day
Last follow-up date
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
2015 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001106

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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