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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025069
Receipt No. R000028840
Scientific Title Therapeutic efficacy and safety of photodynamic therapy in patients with central serous chorioretinopathy
Date of disclosure of the study information 2017/01/31
Last modified on 2016/11/30

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Basic information
Public title Therapeutic efficacy and safety of photodynamic therapy in patients with central serous chorioretinopathy
Acronym Clinical trial of PDT in patients with CSC
Scientific Title Therapeutic efficacy and safety of photodynamic therapy in patients with central serous chorioretinopathy
Scientific Title:Acronym 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
1st name
Middle name
Last name Hisashi Iwami
Organization Hyogo college of Medicine
Division name Ophthalmology
Zip code
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
1st name
Middle name
Last name Hisashi Iwami
Organization Hyogo college of Medicine
Division name Ophthalmology
Zip code
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)

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
2017 Year 01 Month 31 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 Preinitiation
Date of protocol fixation
2016 Year 11 Month 30 Day
Date of IRB
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

Other
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

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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