UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009801 |
|---|---|
| Receipt number | 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 19:19:59 |
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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
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
tsubnkin@hotmail.co.jp
Sponsor or person
Institute
Tokyo medical university
Institute
Department
Personal name
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
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
Value
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 | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
