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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000023200
Receipt No. R000026739
Scientific Title The study of Intravitreal aflibercept with treat and extend regimen for macular edema with branch retinal vein occlusion (BRVO)
Date of disclosure of the study information 2016/09/01
Last modified on 2019/02/21

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Basic information
Public title The study of Intravitreal aflibercept with treat and extend regimen for macular edema with branch retinal vein occlusion (BRVO)
Acronym The study of aflibercept with treat and extend regimen for BRVO
Scientific Title The study of Intravitreal aflibercept with treat and extend regimen for macular edema with branch retinal vein occlusion (BRVO)
Scientific Title:Acronym The study of aflibercept with treat and extend regimen for BRVO
Region
Japan

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

Objectives
Narrative objectives1 To investigate the effectiveness of aflibercept for macular edema due to branch retinal vein occlusion (BRVO) in Japanese patients with prospective treatment regimen (Treat and Extend)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes Change of BCVA from baseline to 12M
Key secondary outcomes 1. Change of OCT from baseline at 12M
2. The number of injections between 12M from baseline
3. Safety

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 Eylea (aflibercept)
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
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. more than 20 years-old, treatment-naive BRVO
2. Visual acuity : 0.1-0.5
3. The duration of BRVO < 3 months
4. outpatients
Key exclusion criteria 1. History of vitrectomy or glaucoma surgery
2. Other disorders such as DME, CRVO or idiopathic macular telangiectasia
3. Poor control hypertension (systolic pressure >180mmHg, diastolic pressure >100mmHg)
4. Concomitant conditions/diseases including uncontrolled glaucoma and intraocular inflammation
5. Patients who the doctor in charge judges are ineligible for the study

Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaaki Saito
Organization Akita University
Division name Department of Ophthalmology
Zip code
Address 44-2 Hasunua-Hiroomote, Akita city, Akita, Japan
TEL 018-834-1111
Email masaaki@med.akita-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaaki Saito
Organization Akita University
Division name Department of Ophthalmology
Zip code
Address 44-2 Hasunua-Hiroomote, Akita city, Akita, Japan
TEL 018-834-1111
Homepage URL
Email masaaki@med.akita-u.ac.jp

Sponsor
Institute Department of Ophthalmology, Akita University
Institute
Department

Funding Source
Organization Bayer Yakuhin Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Akita City Hospital
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
2016 Year 09 Month 01 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 Terminated
Date of protocol fixation
2016 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 17 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
2016 Year 07 Month 16 Day
Last modified on
2019 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026739

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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