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 |
The effect of intravitreal injection of bevacizumab after vitrectomy for proliferative diabetic retinopathy
The effect of intravitreal injection of bevacizumab after vitrectomy
The effect of intravitreal injection of bevacizumab after vitrectomy for proliferative diabetic retinopathy
The effect of intravitreal injection of bevacizumab after vitrectomy
Japan |
proliferative diabetic retinopathy
Ophthalmology |
Others
NO
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.
Efficacy
(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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Medicine |
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.
20 | years-old | <= |
100 | years-old | >= |
Male and Female
It is a case which needs a first time operation at multiplication diabetic retinopathy.
It is IVB medication before an operation.
20
1st name | |
Middle name | |
Last name | Hiroshi Goto |
tokyo medical university
opthalmology
Shinjuku-ku Nishishinjuku6-7-1
1st name | |
Middle name | |
Last name |
Tokyo medical university
Opthalmol
tsubnkin@hotmail.co.jp
Tokyo medical university
Tokyo medical university
Other
NO
2013 | Year | 04 | Month | 01 | Day |
Unpublished
Completed
2013 | Year | 04 | Month | 01 | Day |
2013 | Year | 04 | Month | 01 | Day |
2013 | Year | 01 | Month | 17 | Day |
2018 | Year | 05 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011479