UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036419 |
|---|---|
| Receipt number | R000041494 |
| Scientific Title | Exploratory research in the relation between macular edema and cytokines. |
| Date of disclosure of the study information | 2019/05/01 |
| Last modified on | 2022/04/12 12:55:58 |
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Basic information
Public title
Exploratory research in the relation between
macular edema and cytokines.
Acronym
The relation between macular edema and
cytokines.
Scientific Title
Exploratory research in the relation between
macular edema and cytokines.
Scientific Title:Acronym
The relation between macular edema and
cytokines.
Region
| Japan |
Condition
Condition
Diabetic macular edema and macular edema
with retinal vein occlusion.
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The investigate the relationship between the onset and severity of
macular edema and the type and concentration of cytokines expressed in the anterior aqueous humor and tear fluid.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between macular edema associated with diabetic
retinopathy or retinal vein occlusion and type of
cytokines(cytokine levels in the aqueous humor, tear fluid and blood).
Key secondary outcomes
Relationship between cytokine levels and visual acuity, therapeutic
response, retinal thickness, intraocular pressure, visual field, anterior chamber flare value, fundus autofluorescence, OCT, OCT angiograghy and blood test.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Aflibercept(40mg) simple injection
Interventions/Control_2
Treatment-lessness (nomal)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients whi are outpatients or hospitalized for ophthalmology at
Tokyo Women's Medical College Yachiyo Medical Center.
Patients diagnosed with macular edema associated with diabetic
retinopathy or retinal vein occulusion.
Patients who undergo the intravitreal injection of anti-VEGF drugs or
catacact surgery.
Key exclusion criteria
Patients receiving the intravitreal injection of anti-VEGF drugs with in 3 months of sampling.
Patients receiving the injection suspended steroid within 6 months of
sampling.
Patients without light perception.
Patients who undergo the intraocular surgery within 3 months of
sampling.
In addition, patients who the research director judged as
inappropriate as suject.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hideharu |
| Middle name | |
| Last name | Funatsu |
Organization
Tokyo Women's Medical University Yachiyo Medical center
Division name
Opthalmology
Zip code
276-0046
Address
477-96 Owada-Shinden Yachiyo-shi,Chiba Pref. Japan 276-0046
TEL
047-450-600
funatsu.hideharu@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Kano |
Organization
Tokyo Women's Medical University Yachiyo Medical center
Division name
Opthalmology
Zip code
276-0046
Address
477-96 Owada-Shinden Yachiyo-shi,Chiba Pref. Japan 276-0046
TEL
047-450-600
Homepage URL
mariko.kano0613@gmail.com
Sponsor or person
Institute
Tokyo Women's Medical University Yachiyo Medical center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University Yachiyo Medical center
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
Tokyo Women's Medical University Yachiyo Medical center
Address
477-96 Owada-Shinden Yachiyo-shi,Chiba Pref. Japan 276-0046
Tel
047-450-6000
mariko.kano0613@gmail.com
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
| 2019 | Year | 05 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 05 | Day |
Last modified on
| 2022 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041494
