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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002770
Receipt No. R000003211
Scientific Title Photodynamic therapy with two third dose verteporfin for central serous chorioretinopathy:Prospective intervention trial
Date of disclosure of the study information 2009/11/17
Last modified on 2016/05/17

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Basic information
Public title Photodynamic therapy with two third dose verteporfin for central serous chorioretinopathy:Prospective intervention trial
Acronym Photodynamic therapy with two third dose verteporfin for central serous chorioretinopathy
Scientific Title Photodynamic therapy with two third dose verteporfin for central serous chorioretinopathy:Prospective intervention trial
Scientific Title:Acronym Photodynamic therapy with two third dose verteporfin 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 compare the efficacy and safety of two third dose verteporfin photodynamic therapy(PDT) with half dose for 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 4 days, 1 month, 3 months, 6 months, and 1 year after PDT
Key secondary outcomes 1)visual acuity
2)thickness of retina and serous retinal detachment at fovea on optical coherence tomography
3)choroidal thickness on optical coherence tomography
4)amplitudes and implicit time of a-wave, b-wave and odcillatory potentials recorded by focal macula electroretinogram
5)visual field
6)fluorescein angiography
7)indocyanine green angiography

time of assessment
1)-5) : 4 days, 1 month, 3 months, 6 months, and 1 year after PDT
6),7) : 1 month, 3 months, and 1 year after PDT

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 4mg/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
20 years-old <=
Age-upper limit
70 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(SRD) on optical coherence tomography(OCT)
4. written informed consent
5. re-treatment is considered to the patients with recurrent or persistent SRD on OCT
Key exclusion criteria 1. drug allery to verteporfin
2. pregnant or expecting pregnancy
3. porphyria, or hypersensitivity to artificial illumination
4. macular diseases other than CSC
5. others (inappropriate case judged by investigator or subinvestigators)
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuki Ito
Organization Nagoya University School of Medicine
Division name Department of Ophthalmology
Zip code
Address Tsurumai-cho 65, Showa-ku, Nagoya city, Aichi prefecture
TEL 052-741-2111
Email yasu@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ruka Maruko
Organization Nagoya University School of Medicine
Division name Department of Ophthalmology
Zip code
Address Tsurumai-cho 65, Showa-ku, Nagoya city, Aichi prefecture
TEL 052-741-2111
Homepage URL
Email rutia@xg8.so-net.ne.jp

Sponsor
Institute Nagoya University School of Medicine Department of Ophthalmology
Institute
Department

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
Email

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 名古屋大学医学部附属病院(愛知県)

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 17 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
2009 Year 11 Month 16 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2015 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 11 Month 17 Day
Last modified on
2016 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003211

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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