UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020216
Receipt number R000023348
Scientific Title Quantitative analysis of vitreous and plasma concentrations of brilliant blue G after use as a surgical adjuvant in chromovitrectomy
Date of disclosure of the study information 2015/12/16
Last modified on 2015/12/16 11:17:13

* 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

Quantitative analysis of vitreous and plasma concentrations of brilliant blue G after use as a surgical adjuvant in chromovitrectomy

Acronym

Residualplasma concentrations of BBG after chromovitrectomy

Scientific Title

Quantitative analysis of vitreous and plasma concentrations of brilliant blue G after use as a surgical adjuvant in chromovitrectomy

Scientific Title:Acronym

Residualplasma concentrations of BBG after chromovitrectomy

Region

Japan


Condition

Condition

Chromovitrevictomy for ERM and macular hole

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To analyse vitreous and plasma concentration of BBG after chromovitrectomy

Basic objectives2

PK,PD

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I,II


Assessment

Primary outcomes

Plasma concentrations of BBG after chromovitrectomy

Key secondary outcomes

Vitreous concentrations of BBG after chromovitrectomy


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

Treatment

Type of intervention

Medicine

Interventions/Control_1

Brilliant Blue G

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients required for vitrectomy in one or both eyes
Primary diseases for vitrectomy are macular hole, epiretinal macular membrane, macular hole retinal detachment cased by high myopia , proliferativevitreoretinopathy, preproliferative diabetic retinopathy, diabetic macular edema, macular edema cased by occlusion of retinal vein, and stainig and peeling of internal limiting membrane in vitrectomy are necessary.
2) Age : >=20 years old at the time of obtaining informed consent
3) Male or female passed 2 years after menopause
4) Patients comply with the schedule instructed by PI or SI
5) Patients take part in this trial based on their own free will and give informed consent in written form.

Key exclusion criteria

1) Vitrectomized eye.
2) Has serious of digestive, circulatory, kidney, liver, or blood/coagulation complications
3) Had present and past uveitis or glaucoma
4) Has a history of drug hypersensitivity reactions for Triamcinolone acetonide, mydriatic, antibacterial eyedrops or local anesthetic.
5) Has a history of drug or alcohol abuse
6) Had taken this clinical trial
7) Will take part in in another clinical trial or clinical research during this clinical trial
8) Is deemed unsuitable for this trial by PI or SI

Target sample size

5


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Enaida

Organization

Kyusyu University Hospital, Ohshima Hospital of Ophthalmology

Division name

Ophthalmology

Zip code


Address

3-1-1, Maidashi, Higashi-ku, Fukuoka

TEL

81-92-642-5645

Email

enaida@cc.saga-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Makiko Uchiyama

Organization

Kyusyu University Hospital

Division name

Center for Clinical and Translational Research

Zip code


Address

3-1-1, Maidashi, Higashi-ku, Fukuoka

TEL

81-92-642-6291

Homepage URL


Email

m-uchi@med.kyushu-u.ac.jp


Sponsor or person

Institute

Kyusyu University Hospital, Ohshima Hospital of Ophthalmology

Institute

Department

Personal name



Funding Source

Organization

The Japan Medical Association Center for Clinical Trials

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


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

大島眼科病院


Other administrative information

Date of disclosure of the study information

2015 Year 12 Month 16 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://ovidsp.tx.ovid.com/sp-3.18.0b/ovidweb.cgi?QS2=434f4e1a73d37e8c504983e01e46c99aa269a6408c9ceb4

Number of participants that the trial has enrolled


Results

BBG, which remained at low levels in the vitreous cavity, was not found in the systemic blood flow after the operation. Thus, any adverse effects of systemic BBG would be avoided.

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 02 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 03 Month 01 Day

Last follow-up date

2012 Year 03 Month 31 Day

Date of closure to data entry

2012 Year 05 Month 31 Day

Date trial data considered complete

2012 Year 06 Month 30 Day

Date analysis concluded

2012 Year 08 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 12 Month 16 Day

Last modified on

2015 Year 12 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023348


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name