UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020677 |
|---|---|
| Receipt number | R000023861 |
| Scientific Title | Verteporfin photodynamic therapy for central serous chorioretinopathy |
| Date of disclosure of the study information | 2016/02/01 |
| Last modified on | 2020/07/27 07:40:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Verteporfin photodynamic therapy for central serous chorioretinopathy
Acronym
PDT for CSC
Scientific Title
Verteporfin photodynamic therapy for central serous chorioretinopathy
Scientific Title:Acronym
PDT for CSC
Region
| Japan |
Condition
Condition
Central serous chorioretinopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the outcome of verteporfin photodynamic therapy (PDT) for patients with central serous chorioretinopathy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Visual acuity
Key secondary outcomes
central retinal thickness
central choroidal thickness
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 |
Interventions/Control_1
6mg/m2 verteporfin (Visudyne) is infused over 10 minutes.
15 minutes after beginning the infusion, the total light energy delivered to the area of hyparpermiability was 50J/cm2 for 43 seconds by Semiconductor laser.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
presence of serous retinal detachment
presence of leakage on fluorescein angiography and abnomality dilated choroidal veseles and hyperpermiability on indocyanine angiography
Key exclusion criteria
patients with other retinal diseases
photosensitivity
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nagai Yoshimi |
Organization
Kansai Medical University
Division name
Ophthalmology
Zip code
Address
2-5-1, Shinmachi, Hirakata city, Osaka, JAPAN
TEL
072-804-0101
nagaiy@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nagai Yoshimi |
Organization
Kansai Medical University
Division name
Ophthalmology
Zip code
Address
2-5-1, Shinmachi, Hirakata city, Osaka, JAPAN
TEL
072-804-0101
Homepage URL
nagaiy@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University
Department of Ophthalmology
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
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
| 2016 | Year | 02 | Month | 01 | 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 | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 21 | Day |
Last modified on
| 2020 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023861
