UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009312 |
|---|---|
| Receipt number | R000010934 |
| Scientific Title | Serum concentration of vascular endothelial growth factor of patients with chorioretinal diseases before and after the anti-vascular endothelial growth factor therapy |
| Date of disclosure of the study information | 2012/11/11 |
| Last modified on | 2019/05/17 20:10:55 |
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Basic information
Public title
Serum concentration of vascular endothelial growth factor of patients with chorioretinal diseases before and after the anti-vascular endothelial growth factor therapy
Acronym
Serum VEGF with chorioretinal diseases before and after the anti-VEGF therapy
Scientific Title
Serum concentration of vascular endothelial growth factor of patients with chorioretinal diseases before and after the anti-vascular endothelial growth factor therapy
Scientific Title:Acronym
Serum VEGF with chorioretinal diseases before and after the anti-VEGF therapy
Region
| Japan |
Condition
Condition
diabetic retinopathy, central retinal vein occlusion, branch retinal vein occlusion, age-related macular degeneration, myopic choroidal neovascularization, idiopathic choroidal neovascularization
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the general effect of anti-vascular endothelial growth factor therapy by measuring of serum concentration of vascular endothelial growth factor of patients with chorioretinal diseases before and after the intravitreal injection of anti-vascular endothelial growth factor
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The change of the serum concentration of vascular endothelial growth factor before, 1 week,1 month and 2 months after the injection of anti-vascular endothelial growth factor
Key secondary outcomes
The correlation of best corrected visual acuity or central retinal subfield thickness and serum concentration of vascular endothelial growth factor before, 1 week and 1 month after the injection of anti-vascular endothelial growth factor
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
Observation period: 1 month
Number of treatment: 1
Amount of treatment and method: intravitreal injection of ranibizumab (0.5mg/0.05ml) or bevacizumab (1.25mg/0.05ml) or 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient with active disease, male or female, people 20 years old or older, with informed concent
Key exclusion criteria
Patients without active disease,
severe glaucoma, inflammation eye disease, without informed concent
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masahito |
| Middle name | |
| Last name | Ohji |
Organization
Shiga University of Medical Science
Division name
Department of Ophthalmology
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN 520-2192
TEL
077-548-2276
ohji@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Sawada |
Organization
Shiga University of Medical Science
Division name
Department of Ophthalmology
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN 520-2192
TEL
077-548-2276
Homepage URL
tsawada@belle.shiga-med.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committe of Shiga Univercity of Medical Science
Address
SetaTsukinowa cho, Otsu, JAPAN
Tel
0775483576
hqrec@belle.shiga-med.ac.jp
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
滋賀医科大学附属病院（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 11 | 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
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2012 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 11 | Day |
Last modified on
| 2019 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010934
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