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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013405
Receipt No. R000015643
Scientific Title Evaluation of the efficacy, safety and injection interval of intravitreal injection of aflibercept for central retinal vein occlusion
Date of disclosure of the study information 2014/03/12
Last modified on 2019/03/16

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Basic information
Public title Evaluation of the efficacy, safety and injection interval of intravitreal injection of aflibercept for central retinal vein occlusion
Acronym intravitreal injection of aflibercept for central retinal vein occlusion
Scientific Title Evaluation of the efficacy, safety and injection interval of intravitreal injection of aflibercept for central retinal vein occlusion
Scientific Title:Acronym intravitreal injection of aflibercept for central retinal vein occlusion
Region
Japan

Condition
Condition central retinal vein occlusion
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the efficacy, safety and injection interval of intravitreal injection of aflibercept for central retinal vein occlusion
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Variation on a logarithm of the minimum angle of resolution 12 months after the first intravitreal injection
Key secondary outcomes The rate of complication 12 months after the first intravitreal injection
Variation on a central retinal thickness

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Duration:12 months
Quantity: aflibercept 2.0mg/0.05mL
Bimonthly injection
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 Outpatients of Shiga University of Medical Science Hospital with central retinal vein occlusion that are examined by angiography or checked retinal thickness.
Key exclusion criteria severe renal disease
unstable angina
malignant arrhythmia
history of brain infarction
history of cerebral hemorrhage
severe hypertension
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahito Ohji
Organization Shiga University of Medical Science
Division name Department of Ophthalmology
Zip code
Address Seta Tsukinowa-cho, Otsu, Shiga 520-2192, JAPAN
TEL 0775482276
Email ohji@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshitsugu Saishin
Organization Shiga University of Medical Science
Division name Department of Ophthalmology
Zip code
Address Seta Tsukinowa-cho, Otsu, Shiga 520-2192, JAPAN
TEL 0775482276
Homepage URL
Email saishin@belle.shiga-med.ac.jp

Sponsor
Institute Department of Ophthalmology, Shiga University of Medical Science
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
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 滋賀医科大学附属病院(滋賀県)

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 12 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 Completed
Date of protocol fixation
2013 Year 12 Month 24 Day
Date of IRB
2013 Year 12 Month 24 Day
Anticipated trial start date
2014 Year 03 Month 13 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 03 Month 12 Day
Last modified on
2019 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015643

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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