UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022126 |
|---|---|
| Receipt number | R000025485 |
| Scientific Title | The efficacy and safety of photodynamic therapy for central serous chorioretinopathy |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2020/05/06 16:05:22 |
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Basic information
Public title
The efficacy and safety of photodynamic therapy for central serous chorioretinopathy
Acronym
Photodynamic therapy for central serous chorioretinopathy
Scientific Title
The efficacy and safety of photodynamic therapy for central serous chorioretinopathy
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
To evaluate the efficasy and safety of half dose verteporfin photodynamic therapy for chronic central serous chorioretinopathy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Resolution of serous retinal detachment of 1week, 1month, 3months, 6months, and 1year after photodynamic therapy
Key secondary outcomes
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
3mg/m2 intravenous infusion of verteporfin over 10 minutes followed by delivery of laser at 15 minutes.
Nonthermal laser light of 689nm wavelength is applied for 83 sec delivering a dose of 50J/cm2 at a light intensity of 0.6W/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
| 30 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.3 months or more after onset
2.presence of active angiographic leakage under or adjacent to fovea
in fluorescein angiography
3.presence of serous retinal detachment on optical coherence tomography
4.written informed consent
Key exclusion criteria
1. drug allery to verteporfin
2. pregnant or expecting pregnancy
3. porphyria
4. macular diseases other than central serous chorioretinopathy
5. others (inappropriate case judged by investigator or subinvestigators)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Chie |
| Middle name | |
| Last name | Sotozono |
Organization
Kyoto Prefectual Univercity of Medicine
Division name
Department of Ophthalmology
Zip code
602-8065
Address
465 Kajii cho Hirokoji agaru Kawaramachi dori Kamigyo ku Kyoto
TEL
075-251-5578
csotozon@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Terao |
Organization
Kyoto Prefectual Univercity of Medicine
Division name
Department of Ophthalmology
Zip code
602-8065
Address
465 Kajii cho Hirokoji agaru Kawaramachi dori Kamigyo ku Kyoto
TEL
075-251-5578
Homepage URL
nobu9124@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectual Univercity of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Kyoto Prefectual Univercity of Medicine
Address
465 Kajii cho Hirokoji agaru Kawaramachi dori Kamigyo ku Kyoto
Tel
075-251-5111
rinri@koto.kpu-m.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
| 2016 | Year | 06 | 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
20
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
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | 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 | 04 | Month | 28 | Day |
Last modified on
| 2020 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025485
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
