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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004562
Receipt No. R000005451
Scientific Title Reduced fluence photodynamic therapy combined with intravitreal anti-vascular endothelial growth factor antibody for age-related macular degeneration.
Date of disclosure of the study information 2010/11/15
Last modified on 2016/05/23

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Basic information
Public title Reduced fluence photodynamic therapy combined with intravitreal anti-vascular endothelial growth factor antibody for age-related macular degeneration.
Acronym RFPDT combined with anti-VEGF antibody for AMD.
Scientific Title Reduced fluence photodynamic therapy combined with intravitreal anti-vascular endothelial growth factor antibody for age-related macular degeneration.
Scientific Title:Acronym RFPDT combined with anti-VEGF antibody for AMD.
Region
Japan

Condition
Condition Age-related macular degeneration
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess outcome for patients with AMD treated with RFPDT combined with anti-VEGF.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes vision acuity, disapearment of neovascularization.
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
Interventions/Control_1 RFPDT
anti-VEGFantibody
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
50 years-old <=
Age-upper limit
120 years-old >
Gender Male and Female
Key inclusion criteria Finding choroidal vascular abnormalities with AMD, and vision loss.
Key exclusion criteria the patient without exudative changes in fundus.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidetoshi Yamashita
Organization Yamagata University faculty of Medicine
Division name Department of Ophthalmology
Zip code
Address 2-2-2 Iidanishi Yamagata
TEL 023-628-5374
Email hyama-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shion Hayashi
Organization Yamagata University faculty of Medicine
Division name Department of Ophthalmology
Zip code
Address 2-2-2 iidanishi Yamagata
TEL +81-23-628-5374
Homepage URL
Email shion_haneda055@hotmail.com

Sponsor
Institute Yamagata University Faculty of Medicine
Institute
Department

Funding Source
Organization Yamagata University Faculty of Medicine
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
2010 Year 11 Month 15 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 Terminated
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
2011 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 11 Month 15 Day
Last modified on
2016 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005451

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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