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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009312
Receipt No. 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

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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
Last 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
Email ohji@belle.shiga-med.ac.jp

Public contact
1st 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
Email tsawada@belle.shiga-med.ac.jp

Sponsor
Institute Department of Ophthalmology, Shiga University of Medical Science
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010934

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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