UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy Verification of Photodynamic Therapy for Serous Pigment Epithelial Detachment without Choroidal Neovascularization
Acronym	Photodynamic Therapy for Pigment Epithelial Detachment
Scientific Title	Efficacy Verification of Photodynamic Therapy for Serous Pigment Epithelial Detachment without Choroidal Neovascularization
Scientific Title:Acronym	Photodynamic Therapy for Pigment Epithelial Detachment
Region	Japan

Condition
Condition	Pigment Epithelial Detachment
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify cure rate, improvement rate, improvement factor, and safety of photodynamic therapy for serous pigment epithelial detachment without choroidal neovascularization.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of disappearance of serous pigment epithelial detachment 3 months and 2 years after treatments
Key secondary outcomes	visual acuity, height of pigment epithelial detachment

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Serous pigment epithelial detachment without choroidal neovascularization Central choroidal thickness >= 300 um Desiring the treatment
Key exclusion criteria	History of photodynamic therapy Intraocular surgery within 3 months
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Hidenori Middle name Last name Takahashi
Organization	Jichi Medical University
Division name	Ophthalmology
Zip code	329-0431
Address	3311-1 Yakushiji Shimotsuke-shi Tochigi
TEL	+81285587382
Email	takahah-tky@umin.ac.jp

Public contact
Name of contact person	1st name Hidenori Middle name Last name Takahashi
Organization	Jichi Medical University
Division name	Ophthalmology
Zip code	329-0431
Address	3311-1 Yakushiji Shimotsuke-shi Tochigi
TEL	+81285587382
Homepage URL
Email	takahah-tky@umin.ac.jp

Sponsor
Institute	Jichi Medical University
Institute
Department

Funding Source
Organization	Jichi Medical University
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	Jichi Medical University
Address	3311-1 Yakushiji, Shimotsuke-shi, Tochigi, Japan
Tel	0285-58-7550
Email	rinri@jichi.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 05 Month 23 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	50
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 05 Month 13 Day
Date of IRB	2016 Year 05 Month 24 Day
Anticipated trial start date	2016 Year 05 Month 24 Day
Last follow-up date	2020 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

At Jichi Medical University serous pigment detachment without choroidal neovascularization will receive photodynamic therapy. Photodynamic therapy is to adjust the light-sensitive substance verteporfin to 2 mg / mL, diluted with 1.5 mL / m2 as day stations glucose injection to become a 30mL the (body surface area) as the total amount (5%), over 10 minutes administered intravenously, it is irradiated laser beam to 15 minutes after administration of this drug beginning [wavelength 689 +- 3nm, light irradiation amount of energy 50J / cm2 (83 seconds at an irradiation output 600mW / cm2)] to the treatment spot. Irradiation diameter is greatest linear diameter +1 mm within 7 mm. The optic nerve head should be avoided. The gender, age, pre-treatment and awareness, optical coherence tomography images of the vision, the fundus photos and distortion after treatment for one month, three months, one year, two years extracted from the medical records, the cure rate and the visual acuity improvement and fovea calculate the thinning of the retina thickness and the center choroid thickness, to verify whether pre-treatment visual acuity, retinal thickness, choroidal thickness, sex, and age is related to the degree of healing. If there is a way complications described it. There is no increase the inspection and visit by participating in this study.

Management information
Registered date	2016 Year 05 Month 23 Day
Last modified on	2020 Year 11 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025822