UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023200 |
|---|---|
| Receipt number | 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 12:16:20 |
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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
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
masaaki@med.akita-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Akita University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026739
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
