UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Posterior subtenon injection of triamcinolone acetonide reduces the use of intravitreal bevacizumab for diffuse diabetic macular edema
Title of the study (Brief title)	Combination therapy for DDME
Region	Japan

Condition
Condition	Diffuse Diabetic Macular Edema
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness of posterior subtenon injections of triamcinolone acetonide during treatment with intravitreal injections of bevacizumab in eyes with diffuse diabetic macular edema.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Foveal thickness were monitored monthly for 1-year. The total number of intravitreal injections of bevacizumab injections during the follow-up
Key secondary outcomes	logMAR visual acuity and intraocular pressure

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Initially, both eyes of each patient received 1.25mg/0.05ml of intravitreal injection of bevacizumab. One eye then received 20mg/0.5ml of subtenon injection of triamcinolone acetonide at the onset, and at 16, 32 and 48 weeks. The other eye acted as the control eye and was not treated with subtenon injection of triamcinolone acetonide
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	Type II diabetic patients whose bilateral DDME with foveal thickness greater than 400 micrometer and with logMAR visual acuity worse than 0.3
Key exclusion criteria	Eyes with severe proliferative retinopathy were excluded from the study. Patients with a history of focal or pan retinal photocoagulation and/or cataract surgery in either eye within the 6 months prior to entry into the study, and patients who had previous therapies for DDME, including grid laser treatment, intravitreal injection of any drugs, and/or vitreous surgery, were excluded from this study. Patients with systemic disorders other than hypertension and hypercholesterolemia were excluded from this study.
Target sample size	10

Research contact person
Name of lead principal investigator	Masahiko Shimura
Organization	Tokyo Medical University Hachioji Medical Center
Division name	Department of Ophthalmology
Address	1163 Tate-machi,Hachioji, Tokyo
TEL	090-2274-8107
Email	masahiko@v101.vaio.ne.jp

Public contact
Name of contact person	Masahiko Shimura
Organization	Tokyo Medical University Hachioji Medical Center
Division name	Department of Ophthalmology
Address	1163 Tate-machi,Hachioji, Tokyo
TEL	090-2274-8107
Homepage URL
Email	masahiko@v101.vaio.ne.jp

Sponsor
Institute	NTT East Japan Tohoku Hospital
Institute
Department

Funding Source
Organization	NTT East Japan Tohoku Hospital
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	NTT東日本東北病院

Other administrative information
Date of disclosure of the study information	2013 Year 09 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 01 Day
Anticipated trial start date	2013 Year 09 Month 01 Day
Last follow-up date	2014 Year 12 Month 31 Day
Date of closure to data entry	2014 Year 12 Month 31 Day
Date trial data considered complete	2014 Year 12 Month 31 Day
Date analysis concluded	2015 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/27306783
Results	Subtenon triamcinolone acetonide (STTA)-treated eyes, as compared to their controls, had significantly more regression of foveal thickness (FT) and improvement of visual acuity (VA) at several time points during the study. The required number of intravitreal injection of bevcizumab (IVB) injections in STTA-treated eyes during the study was 5.00 plus-minus 1.75, which was significantly less than 7.95 plus-minus 1.57 in the control eyes.
Other related information

Management information
Registered date	2013 Year 09 Month 05 Day
Last modified on	2016 Year 12 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013632