UMIN-CTR Clinical Trial

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 Shun Middle name Last name Kumashiro
Organization	Toho University Omori Medical Center
Division name	Ophthalmology
Zip code	1438541
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 Shun Middle name Last name Kumashiro
Organization	Toho University Omori Medical Center
Division name	Ophthalmology
Zip code	143-8541
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 Omori Medical Center
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	toho medical school
Address	omori-Nishi,ota-ku,tokyo 143-8541,japan
Tel	03-3762-4151
Email	somu.igakubu@jim.toho-u.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	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	2021 Year 01 Month 14 Day

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