UMIN-CTR Clinical Trial

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
Email	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
Email	nobu9124@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectual Univercity of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025485