UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007482 |
|---|---|
| Receipt number | R000008760 |
| Scientific Title | Low dose of intravitreal bevacizumab (Avastin) used as preoperative adjunct therapy for proliferative diabetic retinopathy |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2014/03/10 20:57:21 |
* 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
Low dose of intravitreal bevacizumab (Avastin) used as preoperative adjunct therapy for proliferative
diabetic retinopathy
Acronym
Low dose of Intravitreal bevacizumab (Avastin) used as preoperative adjunct therapy for proliferative
diabetic retinopathy
Scientific Title
Low dose of intravitreal bevacizumab (Avastin) used as preoperative adjunct therapy for proliferative
diabetic retinopathy
Scientific Title:Acronym
Low dose of Intravitreal bevacizumab (Avastin) used as preoperative adjunct therapy for proliferative
diabetic retinopathy
Region
| Japan |
Condition
Condition
Proliferative diabetic retinopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to verify the usefulness of intravitreal injection of 0.16 mg/0.05 ml bevacizumab one day before conducting vitrectomy for PDR.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Preoperative vitreous VEGF concentration, Number of intraoperative coagulation spots, Number of reoperation caused by recurent postoperative hemorrhage, Post operative Visual acuity, operation time, Kind of tamponade after operation, Number of intrapoerative photocoagulation
Key secondary outcomes
VEGF concentrations in vitreous, surgical time, frequencies of using gas and silicon oil temponade, number of intraoperative laser treatment, frequency of iatrogenic retinal breaks, postoperative (1 month) visual acuity, visual improvement.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Period: 6 months follow up after intravitreal bevacizumab (Avastin) injection for preoperative adjunct therapy.
Dose: Bevacizumab(Avastin) 0.16mg/0.05 ml
Repeat: Single time
Interventions/Control_2
Period: 6 months follow up after vitrectomy
Dose: (-)
Repeat: (-)
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 with proliferative diabetic retinopathy who are indicated for vitrectomy.
Key exclusion criteria
Patients who had undergone intraocular surgery or retinal photocoagulation within 6 months before the study, and those who had undergone intravitreal injection of drugs or sub-Tenon injection of steroids within 6 months before the study were excluded.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ayumu Manabe |
Organization
Surugadai-Hospital, Nihon University
Division name
Division of Ophthalmology, Department of Visual Sciences.
Zip code
Address
1-8-13, Surugadai, Kanda, Chiyoda-ku, Tokyo, Japan
TEL
0332931711
ayumu.m76@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayumu Manabe |
Organization
Surugadai-Hospital, Nihon University
Division name
Division of Ophthalmology, Department of Visual Sciences
Zip code
Address
1-8-13, Surugadai, Kanda, Chiyoda-ku, Tokyo, Japan
TEL
0332931711
Homepage URL
ayumu.m76@gmail.com
Sponsor or person
Institute
Division of Ophthalmology, Department of Visual Sciences, Surugadai-Hospital, Nihon University.
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2012 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2012 | Year | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 09 | Day |
Last modified on
| 2014 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008760
