UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009854
Receipt number R000011544
Scientific Title Randomized controlled clinical trials on the therapeutic effects of triamcinolone acetonide versus bevacizumab for diabetic macular edema
Date of disclosure of the study information 2013/01/25
Last modified on 2023/01/15 18:22:37

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Basic information

Public title

Randomized controlled clinical trials on the therapeutic effects of triamcinolone acetonide versus bevacizumab for diabetic macular edema

Acronym

Randomized controlled clinical trials on the therapeutic effects of triamcinolone acetonide versus bevacizumab for diabetic macular edema

Scientific Title

Randomized controlled clinical trials on the therapeutic effects of triamcinolone acetonide versus bevacizumab for diabetic macular edema

Scientific Title:Acronym

Randomized controlled clinical trials on the therapeutic effects of triamcinolone acetonide versus bevacizumab for diabetic macular edema

Region

Japan


Condition

Condition

diabetic macular edema

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the effect of improving the visual acuity and central retinal thickness with intravitreal injection of triamcinolone acetonide or bevacizumab for diabetic macular edema.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

visual acuity
Foveal thickness and subfoveal choroidal thickness using optical coherent tomography

Key secondary outcomes

Frequency of recurrence
Complications


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Intravitreal injection of triamcinolone acetonide and follow up at least 6 months.

Interventions/Control_2

Intravitreal injection of bevacizumab and follow up at least 6 months.

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Aged 18 years or older.

Diffuse DME(CMT 300microns < determined by OCT).

Visual acuity: 1.0 logMAR >

Key exclusion criteria

Eyes with active proliferative DR.
Eyes with known a history of glaucoma,optic nerve atrophy.
History of laser photocoagulation within 3 months
History of intravitreal injection or subrenon injection for diabetic macular edema within 3months.
Aphakia
Patients with any of serious heart disease, cerebrovascular disease,blood disorder, renal failure, malignant tumor, systemic steroids.
Cases clear OCT images can not be obtained

Patients with known as steroid responder.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Taiji Sakamoto

Organization

Kagoshima University Graduate School of Medical and Dental Science

Division name

Department of Ophthalmology

Zip code


Address

Sakuragaoka 8-35-1, Kagoshima, 890-8520 Japan

TEL

099-275-5402

Email

shou@m3.kufm.kagoshima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shozo Sonoda

Organization

Kagoshima University Graduate School of Medical and Dental Science

Division name

Department of Ophthalmology

Zip code


Address

Sakuragaoka 8-35-1, Kagoshima, 890-8520 Japan

TEL

099-275-5402

Homepage URL


Email

shou@m3.kufm.kagoshima-u.ac.jp


Sponsor or person

Institute

Kagoshima University Graduate School of Medical and Dental Science

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

鹿児島大学病院(鹿児島県)


Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 25 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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 10 Month 01 Day

Date of IRB

2012 Year 10 Month 01 Day

Anticipated trial start date

2012 Year 10 Month 01 Day

Last follow-up date

2015 Year 10 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 01 Month 23 Day

Last modified on

2023 Year 01 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011544


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name