UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Therapeutic efficacy and safety of photodynamic therapy in patients with central serous chorioretinopathy
Title of the study (Brief title)	Clinical trial of PDT in patients with CSC
Region	Japan

Condition
Condition	Central serous chorioretinopathy
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	now writing
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Visual acuity
Key secondary outcomes	Central retinal thickness, fundus autofluorescence

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	Medicine Device,equipment
Interventions/Control_1	now writing
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	15 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	now writing
Key exclusion criteria	A patient with anaphylactic shock against verteporfin
Target sample size	50

Research contact person
Name of lead principal investigator	Hisashi Iwami
Organization	Hyogo college of Medicine
Division name	Ophthalmology
Address	1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan 663-8501
TEL	0798-45-6462
Email	hi-iwami@hyo-med.ac.jp

Public contact
Name of contact person	Hisashi Iwami
Organization	Hyogo college of Medicine
Division name	Ophthalmology
Address	1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan 663-8501
TEL	0798-45-6462
Homepage URL
Email	hi-iwami@hyo-med.ac.jp

Sponsor
Institute	Hyogo college of Medicine
Institute
Department

Funding Source
Organization	Hyogo college of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2017 Year 01 Month 31 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 11 Month 30 Day
Anticipated trial start date	2017 Year 01 Month 31 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	2016 Year 11 Month 30 Day
Last modified on	2016 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028840