UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Treatment of macular edema secondary to branch retinal vein occlusion with sub-tenon triamcinolone acetonide injection
Title of the study (Brief title)	Treatment of macular edema following BRVO with STTA
Region	Japan

Condition
Condition	Macular edema following BRVO
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We evaluate efficacy and safety by observation group and sub-tenon triamcinolone acetonide injection (STTA) (product name:MaQaid ophthalmic injection 40mg) group for macular edema secondary to branch retinal vein occlusion, the patients have characteristics of good prognosis to natural course.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Central Retinal thickness (CRT) for both groups at four weeks.
Key secondary outcomes	Transition of CRT, area under the curve of CRT-monitoring period, logMAR visual acuity, metamorphopsia score, visual analog scale score about vision defect consciousness, and Kaplan-Meier curve based on the number of cases which meet withdrawal criteria and adverse event about VA or CRT.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is 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	STTA will be given on the STTA group and follow-up will be observed
Interventions/Control_2	Follow- up group will be observed
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	Select those who satisfies all the following criteria. 1) Age is between 20 years old and 79 years old. 2) Those whose eye has been diagnosed as BRVO-ME within 6 months before visiting screening inspection. 3) Those who have not been treated by topical medical therapy for BRVO-ME 4) Case that visual acuity and lesion of target patient satisfy the following both items. a) Fractional eyesight is 0.5 or more. b) Lesion of retinal vein branch obstruction lie within 2 papilla area or the shape of lesion wraps from the ear side. 5) Those whose intraocular pressure of the target eye is 21 mmHg or less. 6) Those who can agree the consent of participation for this research by free will in writing
Key exclusion criteria	1) The subject eye has retinal disease except BRVO. 2) Transparency of the subject eye is turbid. 3) Those who have active ocular infection or inactive toxoplasmosis. 4) Those who have glaucoma or ocular hypertension, or medical histories of them. 5) Those who have histories of herpetic infection in their subject eyes. 6) Those who have uncontrollable systemic disease. 7) Those who are systemic debility, or have severe heart disease, severe cerebral blood flow disorder or cirrhosis. 8) Serum creatinine is 2.0 mg/dL or more. 9) Those who have undergone vitreous surgery to the subject eye or who are expected to undergo vitreous surgery. 10) Those who have undertaken the following treatment within 24 weeks or who are expected to be undergone. Administration of corticosteroid to thesubject eye below the Tenon capsule or retro-bulbar. Intravitreal of drug to the subject eye. Administration of immunosuppressant drug, immunomodulatory drug, antimetabolites drug and/or alkylating agents. Hyperbaric oxygen therapy or stellate ganglion block. Hemodialysis or peritoneal dialysis. 11) Those who have received laser or intraocular surgery in the subject eye within 12 weeks or who are expected to undergo them. 12) Those who have received treatments which are corticosteroid, oral carbonic anhydrase inhibitor, warfarin, heparin, heparin analogue, selective thrombin inhibitor, direct thrombin inhibitors or(/and) FXa inhibitors within 4 weeks. Those who are expected to undergo these therapies. 13) Those who are planning of ophthalmic surgery during the observation period. 14) Those who have drug allergy to the drugs which are used in this study. 15) Those who cannot sufficient dilate pupil for inspection. 16) Pregnant or lactating women.
Target sample size	60

Research contact person
Name of lead principal investigator	Motohiro Kamei
Organization	Aichi Medical University
Division name	Department of Ophthalmology
Address	1-1 KarimataYazako, Nagakute, Aichi, 480-1195 JAPAN
TEL	0561-62-3311
Email	motokamei@aichi-med-u.ac.jp

Public contact
Name of contact person	Hasegawa Miyuki
Organization	Aichi Medical University
Division name	Department of Ophthalmology
Address	1-1 KarimataYazako, Nagakute, Aichi, 480-1195 JAPAN
TEL	0561-62-3311
Homepage URL
Email	hasegawa.miyuki.883@mail.cichi-med-u.ac.jp

Sponsor
Institute	Aichi Medicak University Department of Ophthalmology
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	MIYAKE Eye Hospital Kamiiida daiichi General hospital
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	2018 Year 03 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 01 Month 31 Day
Anticipated trial start date	2018 Year 02 Month 28 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

Management information
Registered date	2018 Year 02 Month 08 Day
Last modified on	2018 Year 09 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035508