UMIN-CTR Clinical Trial

Basic information
Public title	Vitrectomy combined with intravitreal triamcinolone acetonide injection for diabetic macular edema
Acronym	Vitrectomy combined with IVTA for DME
Scientific Title
Scientific Title:Acronym
Region	Japan

Condition
Condition	Diabetic macular edema
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of vitrectomy combined with intravitreal injection of triamcinolone acetonide for the treatment of nontractional diabetic macular edema
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Central retinal thickness
Key secondary outcomes

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 Maneuver
Interventions/Control_1	Intra-Vitreal Triamcinolone Acetonide
Interventions/Control_2	Vitrectormy
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Type 2 diabetes Diabetic macular edema Foveal thickness more than 300 micrometers Intraocular pressure less than 21 mmHg Diagnosed as needed vitrectomy
Key exclusion criteria	History of previous vitrectomy. Previous history of treatment with agents including triamcninolone acetonide, anti-VEGF therapy, immunosuppressant drugs and artificial dialysis within 24 weeks. Modification of insulin treatments within 12 weeks. Previous history of laser treatments or intraocular surgery within 12 weeks. Previous history of systemic drugs such as steroid, carbonate dehydratase inhibitor and warfarin within 4 weeks.
Target sample size	60

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Toru Nakazawa
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Ophthalmology
Zip code
Address	1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan
TEL	022-717-7294
Email	ntoru@oph.med.tohoku.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Hiroshi Kunikata
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Ophthalmology
Zip code
Address	1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan
TEL	022-717-7294
Homepage URL
Email	kunikata@oph.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Wakamoto Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
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	2015 Year 05 Month 01 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
Oucome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 03 Month 20 Day
Date of IRB	2015 Year 03 Month 31 Day
Anticipated trial start date	2015 Year 05 Month 01 Day
Last follow-up date	2019 Year 03 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 04 Month 23 Day
Last modified on	2019 Year 03 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018865