UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031352 |
|---|---|
| Receipt number | R000035793 |
| Scientific Title | Visual outcomes of polypoidal choroidal vasculopathy with prompt or deferred treatments or without treatments |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2018/03/27 23:55:48 |
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Basic information
Public title
Visual outcomes of polypoidal choroidal vasculopathy with prompt or deferred treatments or without treatments
Acronym
Polypoidal choroidal vasculopathy with or without treatments
Scientific Title
Visual outcomes of polypoidal choroidal vasculopathy with prompt or deferred treatments or without treatments
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Tsutomu Yasukawa |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL
052-853-8251
yasukawa@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Yasukawa |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL
052-853-8251
Homepage URL
yasukawa@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Partially published
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 | 04 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035793
