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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029429
Receipt No. R000033222
Scientific Title five years result of photodynamic therapy with ranibizumab for polypoidal choroidal vasculopathy
Date of disclosure of the study information 2017/10/05
Last modified on 2017/10/05

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Basic information
Public title five years result of photodynamic therapy with ranibizumab for polypoidal choroidal vasculopathy
Acronym 5 years result of PDT with IVR for PCV
Scientific Title five years result of photodynamic therapy with ranibizumab for polypoidal choroidal vasculopathy
Scientific Title:Acronym 5 years result of PDT with IVR for PCV
Region
Japan

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

Objectives
Narrative objectives1 5 years result of photodynamic therapy with ranibizumab for polypoidal choroidal vasculopathy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The change of best-corrected visual acuity at 1,2,3,4 and 5 years after treatment
Key secondary outcomes The change of central retinal thickness 1,2,3,4 and 5 years after treatment
number of treatments
local and systemic complications

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
56 years-old <=
Age-upper limit
84 years-old >=
Gender Male and Female
Key inclusion criteria treatment-naive polypoidal choroidal vasculopathy
Key exclusion criteria (1) any treatment for PCV prior to PDT,
including laser photocoagulation, transpupillary thermotherapy,or radiotherapy
(2) other concomitant ocular diseases, such as diabetic retinopathy, high myopia, vein or artery occlusion, or epiretinal membrane
(3) any systemic contraindications to verteporfin or angiographic dyes
(4) idiopathic or secondary choroidal neovascularization;
(5) RPE tears or ripping.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Harumi Wakiyama
Organization The Japanese Red Cross Nagasaki Genbaku Hospital
Division name Ophthalmology
Zip code
Address 3-15 Mori-machi, Nagasaki-city
TEL 095-847-1511
Email wakiyama@nagasaki-med.jrc.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Harumi Wakiyama
Organization The Japanese Red Cross Nagasaki Genbaku Hospital
Division name Ophthalmology
Zip code
Address 3-15 Mori-machi, Nagasaki-city
TEL 095-847-1511
Homepage URL
Email wakiyama@nagasaki-med.jrc.or.jp

Sponsor
Institute The Japanese Red Cross Nagasaki Genbaku Hospital
Institute
Department

Funding Source
Organization The Japanese Red Cross Nagasaki Genbaku Hospital
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
Address
Tel
Email

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
2017 Year 10 Month 05 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
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 11 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information retrospective study

Management information
Registered date
2017 Year 10 Month 05 Day
Last modified on
2017 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033222

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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