UMIN-CTR Clinical Trial

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

Macular edema following BRVO

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Aichi Medicak University
Department of Ophthalmology

Institute

Department

Personal name

Organization

Wakamoto Pharmaceutical. Co.ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

MIYAKE Eye Hospital
Kamiiida daiichi General hospital

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

03

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2018

Year

02

Month

08

Day

Last modified on

2018

Year

09

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035508