UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028379 |
|---|---|
| Receipt number | 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 10:12:11 |
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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
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
ystk.imp@gmail.com
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032477
