UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010471
Receipt number R000012237
Scientific Title Safety and effectiveness of selective retina therapy (SRT) for macular edema
Date of disclosure of the study information 2013/05/01
Last modified on 2020/12/17 20:14:22

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Basic information

Public title

Safety and effectiveness of selective retina therapy (SRT) for macular edema

Acronym

Safety and effectiveness of SRT for macular edema

Scientific Title

Safety and effectiveness of selective retina therapy (SRT) for macular edema

Scientific Title:Acronym

Safety and effectiveness of SRT for macular edema

Region

Japan


Condition

Condition

diabetic maculopathy, branch retinal vein occlusion, central retinal vein occlusion, age-related macular degeneration, persistent serous retinal detachment, postoperative residual retinal detachment

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Safety and effectiveness of selective retina therapy (SRT) for patients with macuar edema

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

observation of optic coherence tomography

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

methods:
After local anesthesia with Benoxil ophthalmic solution, we irradiate SRT laser for the lesion.

periodical evaluation:
Three months after first therapy, we retreat if the treatment is inadequate. We will make a follow-up one year after the first treatment.

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

patients with macular edema caused subjective symptoms such as central scotoma, metamorphopsia and central visual loss

Key exclusion criteria

ophthalmic exclusion criteria:
patients who had inflammation within the eye

systemic exclusion criteria:
people who had systemic inflammatory disease, hemorrhagic diathesis or anticoagulant therapy, untreated hypertension or diabetes mellitus. peple who is pregnant or at risk of becoming pregnant.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Manabu
Middle name
Last name Yamamoto

Organization

Osaka City University, Graduate School of Medicine, Department of Ophthalmology and Visual sciences

Division name

Ophthalmology

Zip code

545-8585

Address

1-4-3, Asahi-machi, Abenoku, Osaka-shi, Japan

TEL

06-6645-3867

Email

manabun@msic.med.osaka-cu.ac.jp


Public contact

Name of contact person

1st name Manabu
Middle name
Last name Yamamoto

Organization

Osaka City University, Graduate School of Medicine, Department of Ophthalmology and Visual sciences

Division name

Ophthalmology

Zip code

545-8585

Address

Osaka City University, Graduate School of Medicine, Department of Ophthalmology and Visual sciences

TEL

06-6645-3867

Homepage URL


Email

manabun@msic.med.osaka-cu.ac.jp


Sponsor or person

Institute

Osaka City University, Graduate School of Medicine, Department of Ophthalmology and Visual sciences

Institute

Department

Personal name



Funding Source

Organization

Osaka City University, Graduate School of Medicine, Department of Ophthalmology and Visual sciences

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Osaka City University Hospital Certified Review Board

Address

1-2-7-601, Asahi-machi, Abeno-ku, Osaka, Japan

Tel

06-6645-3456

Email

ethics@med.osaka-cu.ac.jp


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

2013 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


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2012 Year 11 Month 02 Day

Date of IRB

2012 Year 09 Month 28 Day

Anticipated trial start date

2013 Year 01 Month 09 Day

Last follow-up date

2017 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 04 Month 11 Day

Last modified on

2020 Year 12 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012237


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name