UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Photodynamic therapy with two third dose verteporfin for central serous chorioretinopathy:Prospective intervention trial
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yasuki Ito
Organization	Nagoya University School of Medicine
Division name	Department of Ophthalmology
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	Ruka Maruko
Organization	Nagoya University School of Medicine
Division name	Department of Ophthalmology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 11 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000003211