UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Visual outcomes of polypoidal choroidal vasculopathy with prompt or deferred treatments or without treatments
Title of the study (Brief title)	Polypoidal choroidal vasculopathy with or without treatments
Region	Japan

Condition
Condition	Polypoidal choroidal vasculopathy
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Polypoidal choroidal vasculopathy (PCV) is currently treated with anti-vascular endothelial growth factor (VEGF) therapies and photodynamic therapy (PDT). However, there are many cases, which cannot undergo any treatments due to various reasons practically but preserve good vision over years. The purpose of this study is to compare visual outcomes of eyes with PCV with and without prompt treatments.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	(1) Changes in best-corrected visual acuity (2) Timing and the number of treatments
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	photodynamic therapy (PDT)
Interventions/Control_2	anti-vascular endothelial growth factor (VEGF) therapy
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients, who consulted a ophthalmologist in Nagoya City University Hospital between April 2009 and March 2017 and were diagnosed as polypoidal choroidal vasculopathy (PCV) with a baseline best corrected visual acuity (BCVA) of 20/200 or better
Key exclusion criteria	1. past history of photocoagulation or photodynamic therapy or anti-vascular endothelial growth factor therapy 2. presence of other macular diseases 3. presence of uveitis 4. past history of vitrectomy 5. hazy media causing difficulties in fun dus examinations 6. pregnant or planned for pregnancy 7. undergone intraocular surgeries within the previous 6 months 8. judged by the investigator to be ineligible for other reasons
Target sample size	50

Research contact person
Name of lead principal investigator	Tsutomu Yasukawa
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Ophthalmology and Visual Science
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL	052-853-8251
Email	yasukawa@med.nagoya-cu.ac.jp

Public contact
Name of contact person	Tsutomu Yasukawa
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Ophthalmology and Visual Science
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL	052-853-8251
Homepage URL
Email	yasukawa@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization	Nagoya City University Graduate School of Medical Sciences
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

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 04 Month 01 Day
Anticipated trial start date	2009 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 02 Month 18 Day
Last modified on	2018 Year 03 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035793