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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name