UMIN-CTR Clinical Trial

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

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012237