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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026850
Receipt No. R000030814
Scientific Title Photodynamic therapy for central serous chorioretinopathy, idiopathic choroidal neovascular disease, myopic choroidal neovascular disease
Date of disclosure of the study information 2017/04/11
Last modified on 2017/04/03

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Basic information
Public title Photodynamic therapy for central serous chorioretinopathy, idiopathic choroidal neovascular disease, myopic choroidal neovascular disease
Acronym Photodynamic therapy for central serous chorioretinopathy
Scientific Title Photodynamic therapy for central serous chorioretinopathy, idiopathic choroidal neovascular disease, myopic choroidal neovascular disease
Scientific Title:Acronym Photodynamic therapy for central serous chorioretinopathy
Region
Japan

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

Objectives
Narrative objectives1 There is no insurance indication for central serous chorioretinopathy, photodynamic therapy can not be performed, and for invalid cases such as anti-VEGF drugs, treatment is only Tenon's subcutaneous injection of steroid, oral medicine for improving retinal circulation etc. only.
Photodynamic therapy for the above diseases has been announced for many years, and Toho University Medical Center Omori Hospital also stipulates strict adaptation and wishes to use it in cases where it is deemed beneficial to patients.



































































Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation items of central serous chorioretinopathy were evaluated by visual acuity, foveal retinal thickness, choroidal thickness, ocular blood flow, fluorescence ocular fundus angiography examination, before, 2 weeks, 1 month, 3 months after the evaluation To














Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Photodynamic therapy was carried out in 1/2 dose, usually used for age-related macular degeneration, and the amount of visudain was measured before, during, 2 weeks after operation, 1 month, 3 months, visual acuity, foveal net thickness, choroidal thickness, Fluorescence fundus angiography examination, examination of ocular blood flow and evaluation
Interventions/Control_2 Photodynamic therapy was carried out in 1/3 dose, usually used for age-related macular degeneration, and the amount of visudain was measured before, during, 2 weeks after operation, 1 month, 3 months, visual acuity, foveal net thickness, choroidal thickness, Fluorescence fundus angiography examination, examination of ocular blood flow and evaluation
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
70 years-old >=
Gender Male and Female
Key inclusion criteria A case of subretinal fluid present in the foveal region over 3 months
Examples of difficulty with photocoagulation treatment due to escape from the fovea central fossa and extensive leakage
Cases from 20 to 70 years old
Key exclusion criteria (1) Examples in which photodynamic therapy was previously performed or local retinal photocoagulation for treating central serous chorioretinopathy
(2) Complicated cases of choroidal neovascularization or other macular diseases
(3) Combination of choroidal diseases that may affect the thickness of the choroid
(4) Examples of anti-VEGF drugs
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shun Kumashiro
Organization Toho University Omori Medical Center
Division name Ophthalmology
Zip code
Address 6-11-1omori-nishi ota-ku tokyo 143-8541 japan
TEL 03-3762-4151
Email shun.kumashiro@med.toho-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shun Kumashiro
Organization Toho University Omori Medical Center
Division name Ophthalmology
Zip code
Address 6-11-1omori-nishi ota-ku tokyo 143-8541 japan
TEL 03-3762-4151
Homepage URL
Email shun.kumashiro@med.toho-u.ac.jp

Sponsor
Institute Toho University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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 04 Month 11 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 08 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 04 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
2017 Year 04 Month 03 Day
Last modified on
2017 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030814

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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