UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027100 |
|---|---|
| Receipt number | R000031059 |
| Scientific Title | Aflibercept treat and extend for macular edema secondary to branch retinal vein occlusion |
| Date of disclosure of the study information | 2017/04/24 |
| Last modified on | 2017/04/22 13:01:26 |
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Basic information
Public title
Aflibercept treat and extend for macular edema secondary to branch retinal vein occlusion
Acronym
Aflibercept treat and extend for branch retinal vein occlusion
Scientific Title
Aflibercept treat and extend for macular edema secondary to branch retinal vein occlusion
Scientific Title:Acronym
Aflibercept treat and extend for 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 investigate best corrected visual acuity and retinal sensitivity at 12 months after intravitreal aflibercept treat and extend vs PRN for macular edema secondary to branch retinal vein occlusion
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in best corrected visual acuity at 12 months after intravitreal aflibercept
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
aflibercept treat and extend
Interventions/Control_2
aflibercept prn
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Naive BRVO
2.BCVA 0.1-1.0
3.Disease duration < 3 months
4.NPA< 5DD
Key exclusion criteria
1.Past history of vitrectomy or glaucoma surgery
2.Cataract surgery within 3 months
3.patients with diabetic retinopathy or central vein occlusion
4.IOP poor control
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Sakai |
Organization
Jikei daisan hospital
Division name
Ophthalmology
Zip code
Address
4-11-1 izsumihoncho, komae, Tokyo
TEL
0334801151
tstmski@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Sakai |
Organization
Jikei daisan hospital
Division name
Ophthalmology
Zip code
Address
4-11-1 izsumihoncho, komae, Tokyo
TEL
0334801151
Homepage URL
tstmski@jikei.ac.jp
Sponsor or person
Institute
Jikei daisan hospital
Institute
Department
Personal name
Funding Source
Organization
Bayer
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2017 | Year | 04 | Month | 24 | 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
Date of protocol fixation
| 2016 | Year | 11 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 24 | 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 | 22 | Day |
Last modified on
| 2017 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031059
