UMIN-CTR Clinical Trial

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