UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008819 |
|---|---|
| Receipt number | R000010363 |
| Scientific Title | Study on the efficacy and safety of reduced-fluence photodynamic therapy for chronic central serous chorioretinopathy |
| Date of disclosure of the study information | 2012/11/01 |
| Last modified on | 2014/10/06 07:15:56 |
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Basic information
Public title
Study on the efficacy and safety of reduced-fluence photodynamic therapy for chronic central serous chorioretinopathy
Acronym
Reduced-fluence photodynamic therapy for chronic central serous chorioretinopathy
Scientific Title
Study on the efficacy and safety of reduced-fluence photodynamic therapy for chronic central serous chorioretinopathy
Scientific Title:Acronym
Reduced-fluence photodynamic therapy for chronic central serous chorioretinopathy
Region
| Japan |
Condition
Condition
chronic central serous chorioretinopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of reduced-fluence photodynamic therapy for chronic central serous chorioretinopathy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
resolution of serous retinal detachment of 7 days, 1 month, 3 months, 6 months and 1 year after reduced-fluence photodynamic therapy
Key secondary outcomes
1) visual acuity
2) optical coherence tomography
3) fluorescein angiography
4) indocyanine green angiography
evaluation time
1), 2): 7 days, 1 month, 3 months, 6 months, 1 year after RF-PDT
3), 4): 1 month, 3 months, 1 year after RF-PDT
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 | Maneuver |
Interventions/Control_1
6mg/m2 intravenous infusion of verteporfin followed by delivery of laser 15 minutes after the start of the infusion. Light dose rate is 300mW/cm2, time of photosensitization is 83 seconds, and total light energy is 25J/cm2.
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
1) 3 months or more after onset
2) presence of angiographic leakage under fovea in
fluorescein angiography
3) presence of serous detachment on optical coherence
tomography
4) obtain written informed consent
Key exclusion criteria
1) drug allergy to verteporfin
2) porphyria, or hypersensitivity to artificial illumination
3) macular diseases other than central serous
chorioretinopathy
4) pregnant or expecting pregnancy
5) others, inappropriate case judged by investigator or
subinvestigators
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Mizukawa |
Organization
Kawasaki Medical School Hospital
Division name
Ophthalmology
Zip code
Address
577 Matsushima, Kurashiki, Okayama 701-0192, Japan
TEL
086-462-1111
mizu-p@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Mizukawa |
Organization
Kawasaki Medical School Hospital
Division name
Ophthalmology
Zip code
Address
577 Matsushima, Kurashiki, Okayama 701-0192, Japan
TEL
086-462-1111
Homepage URL
kmsrec@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School Hospital
Department of Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2012 | Year | 11 | 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
Completed
Date of protocol fixation
| 2012 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 25 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 25 | Day |
Date trial data considered complete
| 2014 | Year | 08 | Month | 25 | Day |
Date analysis concluded
| 2014 | Year | 08 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 31 | Day |
Last modified on
| 2014 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010363
