UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026850 |
|---|---|
| Receipt number | 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 | 2021/01/14 10:54:04 |
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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 | 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
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
shun.kumashiro@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Omori Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030814
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