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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000009801
Receipt No. R000011479
Scientific Title The effect of intravitreal injection of bevacizumab after vitrectomy for proliferative diabetic retinopathy
Date of disclosure of the study information 2013/04/01
Last modified on 2018/05/22

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Basic information
Public title The effect of intravitreal injection of bevacizumab after vitrectomy for proliferative diabetic retinopathy
Acronym The effect of intravitreal injection of bevacizumab after vitrectomy
Scientific Title The effect of intravitreal injection of bevacizumab after vitrectomy for proliferative diabetic retinopathy
Scientific Title:Acronym The effect of intravitreal injection of bevacizumab after vitrectomy
Region
Japan

Condition
Condition proliferative diabetic retinopathy
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1
The VEGF concentration in the vitreous humor of the patient who enforces vitreous surgery to multiplication diabetic retinopathy is measured, and eye internal-ordering ON of the Bevacizumab (AvastinOR) which is a monoclonal antibody to VEGF is carried out to the patient who was 1,000 pg/more than ml.
The prevention method of postoperative vitreous hemorrhage is established by measuring the frequency of postoperative complications with the conventional postoperative progress about the curative effect.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (1) Primary endpoint
Frequency of postoperative vitreous body re-bleeding
(2) Secondary endpoint
A. Evaluation of the activity of the new blood vessel by the anterior ocular segment photograph and a fundus-of-the-eye photograph
B. Evaluation of the activity of the new blood vessel by fluorescence fundus-of-the-eye imaging
C. The improvement factor of eyesight
D. The improvement factor of the thickness of the retina by an optical interference fault meter
E. The improvement factor of intraocular pressure
Key secondary outcomes

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 Prevention
Type of intervention
Medicine
Interventions/Control_1 The VEGF concentration in vitreous humor carries out intravitreal administration of AvastinOR by visitors to the case which was 1,000 pg(s)/ml.
Under clean, one vial (100 mg/four ml) of AvastinOR is subdivided into a vial, it saves it 0.4 ml at a time, and necessary quantity is taken and used for a one patient from this one subdivided vial.
The circumference of an eye is disinfected enough in Isodine before injection, and applying-eyewash anesthesia is performed.
Then, 1.25 mg/0.05 ml of AvastinOR is taken to syringe, and it pours in into a vitreous body using 30G stitch.
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
100 years-old >=
Gender Male and Female
Key inclusion criteria It is a case which needs a first time operation at multiplication diabetic retinopathy.
Key exclusion criteria It is IVB medication before an operation.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Goto
Organization tokyo medical university
Division name opthalmology
Zip code
Address Shinjuku-ku Nishishinjuku6-7-1
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tokyo medical university
Division name Opthalmol
Zip code
Address
TEL
Homepage URL
Email tsubnkin@hotmail.co.jp

Sponsor
Institute Tokyo medical university
Institute
Department

Funding Source
Organization Tokyo medical university
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 04 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 Completed
Date of protocol fixation
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 01 Month 17 Day
Last modified on
2018 Year 05 Month 22 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011479

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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