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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000031215
Receipt No. R000035508
Scientific Title Treatment of macular edema secondary to branch retinal vein occlusion with sub-tenon triamcinolone acetonide injection
Date of disclosure of the study information 2018/03/01
Last modified on 2018/09/25

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Basic information
Public title Treatment of macular edema secondary to branch retinal vein occlusion with sub-tenon triamcinolone acetonide injection
Acronym Treatment of macular edema following BRVO with STTA
Scientific Title Treatment of macular edema secondary to branch retinal vein occlusion with sub-tenon triamcinolone acetonide injection
Scientific Title:Acronym 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
1st name
Middle name
Last name Motohiro Kamei
Organization Aichi Medical University
Division name Department of Ophthalmology
Zip code
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
1st name
Middle name
Last name Hasegawa Miyuki
Organization Aichi Medical University
Division name Department of Ophthalmology
Zip code
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)

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
2018 Year 03 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
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2018 Year 01 Month 31 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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