UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of intravitreal injection of bevacizumab after vitrectomy for proliferative diabetic retinopathy
Title of the study (Brief title)	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	Hiroshi Goto
Organization	tokyo medical university
Division name	opthalmology
Address	Shinjuku-ku Nishishinjuku6-7-1
TEL
Email

Public contact
Name of contact person
Organization	Tokyo medical university
Division name	Opthalmol
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011479