UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of intravitreal triamcinolone injection combined with vitrectomy for proliferative diabetic retinopathy.
Title of the study (Brief title)	Effect of intravitreal triamcinolone injection combined with vitrectomy for proliferative diabetic retinopathy.
Region	Japan

Condition
Condition	Diabetic retinopathy
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine whether intravitreal triamcinolone injection combined with vitrectomy prevent postoperative inflammation and macular edema worsening.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Central retinal thickness (3 days, 1 week, and 1, 3, 6, 12 months after vitrectomy)
Key secondary outcomes	Postoperative visual acuity, flare value in anterior chamber, intraocular pressure, and number of intraoperative photocoagulation(3 days, 1 week, and 1, 3, 6, 12 months after vitrectomy)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Triamcinolone acetonide, 4mg, intravitreal injection
Interventions/Control_2	Control group
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 with the document agreement 2) Patients with diabetes mellitus 3) Patients with proliferative diabetic retinopathy who were scheduled vitrectomy
Key exclusion criteria	1) Patients who received intravitreal triamcinolone injection within three months 2) Patients receiving systemic therapy of steroid drugs 3) Patients who was judged to be inappropriate as a subject by doctor in charge
Target sample size	60

Research contact person
Name of lead principal investigator	Takehiro Matsumura
Organization	Faculty of Medical Science, University of Fukui
Division name	Ophthalmology
Address	23-3 Shimoaiduki, Matsuoka, Yoshida, Fukui
TEL	0776-61-8403
Email	tmatsu@u-fukui.ac.jp

Public contact
Name of contact person	Takehiro Matsumura
Organization	Faculty of Medical Science, University of Fukui
Division name	Ophthalmology
Address	23-3 Shimoaiduki, Matsuoka, Yoshida, Fukui
TEL	0776-61-8403
Homepage URL
Email	tmatsu@u-fukui.ac.jp

Sponsor
Institute	Department of Ophthalmology, Faculty of Medical Science, University of Fukui
Institute
Department

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)

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	福井大学医学部附属病院（福井県）、信州大学医学部附属病院（長野県）、三重大学医学部附属病院（三重県）、東京医科大学八王子医療センター（東京都）、徳島大学病院（徳島県）、東京女子医科大学糖尿病センター（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 27 Day
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 02 Month 05 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 12 Month 28 Day
Last modified on	2018 Year 02 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023531