UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013974
Receipt No. R000011791
Scientific Title The effect of intra-vitreal injection of bevacizumab for vascular endothelial factor-related intraocular diseases.
Date of disclosure of the study information 2014/05/19
Last modified on 2019/05/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The effect of intra-vitreal injection of bevacizumab for vascular endothelial factor-related intraocular diseases.
Acronym The effcet of intra-vitreal bevacizumab.
Scientific Title The effect of intra-vitreal injection of bevacizumab for vascular endothelial factor-related intraocular diseases.
Scientific Title:Acronym The effcet of intra-vitreal bevacizumab.
Region
Japan

Condition
Condition choroidal neovascularization, retinal vein occlusion, diabetic retinopathy, diabetic maculopathy, neovascular glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of the intravitreal bevacizumab for vascular endothelial factor-related intraocular disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Varidation on the visula acuity at 1, 3, 6, 12 months after intravitreal injection
Key secondary outcomes Examination of macular forrmation and thickness by optical coherence tomography

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 Intravitreal injection
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 Patients at Matsumoto Dental University with choroidal neovasucularization, retinal vein occlusion, diabetic retionopathy, uveitis, and neovascular glaucoma.
Key exclusion criteria Patietns with uncontroled hypertension or with systemic risk factors of cerebral infarction or cardial infarction.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kouichi
Middle name
Last name Ohta
Organization Matsumoto Dental Univeristy
Division name Ophthalmology
Zip code 399-0781
Address 1780 Gobara, Hiooka, Shiojiri
TEL 0263-51-2360
Email ohta@p.mdu.ac.jp

Public contact
Name of contact person
1st name Kouichi
Middle name
Last name Ohta
Organization Matsumoto Dental University
Division name Ophthalmology
Zip code 399-0781
Address 1780 Gobara, Hirooka, Shiojiri
TEL 0263-51-2360
Homepage URL
Email ohta@po.mdu.ac.jp

Sponsor
Institute Department of Ophthalmology, Matsumoto Dental University
Institute
Department

Funding Source
Organization Department of Ophthalmology,
Matsumoto Dental 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 Matsumoto Dental University
Address 1780 Gobara, Hirooka, Shiojiri
Tel 0263-51-2188
Email info_kakenhi@po.mdu.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 松本歯科大学病院

Other administrative information
Date of disclosure of the study information
2014 Year 05 Month 19 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 3
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 Terminated
Date of protocol fixation
2013 Year 03 Month 25 Day
Date of IRB
2013 Year 03 Month 31 Day
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
2019 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 05 Month 16 Day
Last modified on
2019 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011791

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.