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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028379
Receipt No. R000032477
Scientific Title Changes in retinal microcirculation after intravitreal aflibercept in eyes with macular edema secondory to branch retinal vein occlusion
Date of disclosure of the study information 2017/07/31
Last modified on 2017/07/26

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Basic information
Public title Changes in retinal microcirculation after intravitreal aflibercept in eyes with macular edema secondory to branch retinal vein occlusion
Acronym Changes in retinal microcirculation after intravitreal aflibercept in eyes with macular edema secondory to branch retinal vein occlusion
Scientific Title Changes in retinal microcirculation after intravitreal aflibercept in eyes with macular edema secondory to branch retinal vein occlusion
Scientific Title:Acronym Changes in retinal microcirculation after intravitreal aflibercept in eyes with macular edema secondory to 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 evaluate the effects of an intravitreal aflibercept (IVA) injection on the retinal microcirculation of eyes with macular edema secondary to a branch retinal vein occlusion (BRVO) by laser speckle flowgraphy(LSFG)
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Blood flow of retinochoroidal blood vessel
Key secondary outcomes Choroidal vascular area
Choroidal thickness
Inra-ocular pressure

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 One dose of intravitreal aflibercept(2mg/0.05ml)
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
90 years-old >
Gender Male and Female
Key inclusion criteria Eyes with macular edema secondary to branch retinal vein occlusion
Key exclusion criteria Presence of eye disease
History of eye disease treatment
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Iwase
Organization Nagoya University School of Medicine
Division name Department of Opthlamology
Zip code
Address Tsurumai-cho 65, Showa-ku, Nagoya city, Aichi prefecture
TEL 052-744-2275
Email tiwase@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshitaka Ueno
Organization Nagoya University School of Medicine
Division name Department of Opthalmology
Zip code
Address Tsurumai-cho 65, Showa-ku, Nagoya city, Aichi prefecture
TEL 052-744-2275
Homepage URL
Email ystk.imp@gmail.com

Sponsor
Institute Nagoya University
Institute
Department

Funding Source
Organization Nagoya University
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
2017 Year 07 Month 31 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
2017 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 08 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 07 Month 26 Day
Last modified on
2017 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032477

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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