UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intravitreal triamcinolone acetonide combined withccataract surgery for diabetic macular edema
Title of the study (Brief title)	IVTA with cataract for DME
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effectiveness of an intravitreal triamcinolone acetonide injection (IVTA) combined with cataract surgery for the diabetic macular edema (DME) resist to anti-vascular endothelial growth factor (anti-VEGF).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visual acuity after treatment
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	All of the patients had received IVTA combined with phacoemulsification and aspiration cataract surgery and intraocular lens implantation between December 2014 and December 2016. The inclusion criteria were patients who were resistant to previous treatments such as retinal photocoagulation, intravitreal injections of anti-VEGF agents, or sub-tenon triamcinolone acetonide injections(STTA), had a medical history of systemic diseases such as myocardial infarction, cerebral infarction, or cerebral hemorrhage, and had financial difficulty in paying for the anti-VEGF treatments. The CRT of all the patients was over 300 um as determined by fluorescein angiography(FAG)and optical coherence tomography(OCT). A recurrence was defined as an increase in the CRT by 20% compared to the minimum CRT value during the observation period.
Key exclusion criteria	Patients were excluded if they had the macular traction syndrome, active proliferative diabetic retinopathy, uveitis, poorly controlled ocular hypertension, glaucoma, had intraocular surgery within the past 6 months, and history of anti-VEGF treatment or STTA, or had macular photocoagulation within the past 3 months before the beginning of the treatment. Patients who had adverse reactions to steroids were also excluded.
Target sample size	30

Research contact person
Name of lead principal investigator	Masahiko Sugimoto
Organization	Mie University Graduate School of Medicine
Division name	Department of Ophthalmology
Address	2-174 Edobashi, Tsu, 514-8507, Japan
TEL	059-232-1111
Email	sugmochi@aqua.ocn.ne.jp

Public contact
Name of contact person	Masahiko Sugimoto
Organization	Mie University Graduate School of Medicine
Division name	Department of Ophthalmology
Address	2-174 Edobashi, Tsu, 514-8507, Japan
TEL	059-232-1111
Homepage URL
Email	sugmochi@aqua.ocn.ne.jp

Sponsor
Institute	Department of Ophthalmology, Mie University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Ophthalmology, Mie University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 25 Day
Anticipated trial start date	2015 Year 11 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	None

Management information
Registered date	2017 Year 11 Month 03 Day
Last modified on	2018 Year 08 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034067