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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027003
Receipt No. R000030963
Scientific Title CORRELATION BETWEEN SHORT- AND LONG-TERM EFFECTS OF INTRAVITREAL RANIBIZUMAB THERAPY ON MACULAR EDEMA AFTER BRANCH RETINAL VEIN OCCLUSION
Date of disclosure of the study information 2017/04/15
Last modified on 2017/04/15

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Basic information
Public title CORRELATION BETWEEN SHORT- AND LONG-TERM EFFECTS OF INTRAVITREAL RANIBIZUMAB THERAPY ON MACULAR EDEMA
AFTER BRANCH RETINAL VEIN OCCLUSION
Acronym CORRELATION BETWEEN SHORT- AND LONG-TERM EFFECTS OF INTRAVITREAL RANIBIZUMAB THERAPY ON MACULAR EDEMA
AFTER BRANCH RETINAL VEIN OCCLUSION
Scientific Title CORRELATION BETWEEN SHORT- AND LONG-TERM EFFECTS OF INTRAVITREAL RANIBIZUMAB THERAPY ON MACULAR EDEMA
AFTER BRANCH RETINAL VEIN OCCLUSION
Scientific Title:Acronym CORRELATION BETWEEN SHORT- AND LONG-TERM EFFECTS OF INTRAVITREAL RANIBIZUMAB THERAPY ON MACULAR EDEMA
AFTER 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 assess the correlation between the short- and long-term effects of intravitreal ranibizumab (IVR) on macular edema after branch retinal vein occlusion (BRVO).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The primary endpoint was the change from baseline in the best-corrected visual acuity
at 1 day and 6 months after the intravitreal ranibizumab injection.
Key secondary outcomes

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 intravitreal ranibizumab injection for 6 months
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
30 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria The inclusion criteria were the presence of macular edema that involved the fovea after development of BRVO before therapy (foveal thickness [FT] at baseline more than 300 microns), no history of IVR injection, and no history of other treatments for macular edema within the previous 3 months.
Key exclusion criteria The exclusion criteria were the presence of other retinal diseases such as diabetic retinopathy and age-related macular degeneration.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiro Minami
Organization Nayoro city general hospital
Division name medical examination section
Zip code
Address nishi 8 minami 7-1 nayoro hokkaido japan
TEL 0165433101
Email y37373m@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiro Minami
Organization Nayoro city general hospital
Division name medical examination section
Zip code
Address nishi 8 minami 7-1 nayoro hokkaido japan
TEL 0165433101
Homepage URL
Email y37373m@yahoo.co.jp

Sponsor
Institute Nayoro city general hospital
Institute
Department

Funding Source
Organization Nayoro city general hospital
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 名寄市立総合病院

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 15 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 Completed
Date of protocol fixation
2013 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 10 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

Management information
Registered date
2017 Year 04 Month 15 Day
Last modified on
2017 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030963

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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