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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016870
Receipt No. R000019582
Scientific Title Combination therapy with intravitreal tissue plasminogen activator and ranibizumab for subfoveal type 2 choroidal neovascularization
Date of disclosure of the study information 2015/03/23
Last modified on 2015/03/22

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Basic information
Public title Combination therapy with intravitreal tissue plasminogen activator and ranibizumab for subfoveal type 2 choroidal neovascularization
Acronym Intravitreal tPA and ranibizumab for type 2 choroidal neovascularization
Scientific Title Combination therapy with intravitreal tissue plasminogen activator and ranibizumab for subfoveal type 2 choroidal neovascularization
Scientific Title:Acronym Intravitreal tPA and ranibizumab for type 2 choroidal neovascularization
Region
Japan

Condition
Condition Subfoveal type 2 choroidal neovascularization
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate additional impacts of intravitreal tissue plasminogen activator, a fibrinolytic compound combined with intravitreal ranibizumab (IVR) on subfoveal type 2 choroidal neovascularization
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Best-ocrrected visual acuity
Key secondary outcomes central retinal thickness and macular volume on optical coherence tomography

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 intravitreal tissue plasminogen activator + ranibizumab
Interventions/Control_2 intravitreal ranibizumab
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 eyes diagnosed as subfoveal type 2 CNV associated with AMD without massive subretinal hemorrhage over 1 disc diameter and with baseline best-corrected visual acuity (BCVA) between 20/200 and 20/40
Key exclusion criteria eyes with previous photodynamic therapy, medication for glaucoma, diabetic retinopathy, epiretinal membrane, vitreomacular traction, or high myopia (-6.0 diopters or worse)
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsutomu Yasukawa
Organization Nagoya City University Graduate School of Medicine
Division name Department of Ophthalmology and Visual Science
Zip code
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, JAPAN
TEL +81-52-853-8251
Email 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 Ophthalmology and Visual Science
Zip code
Address Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Aichi 467-8601, JAPAN
TEL +81-52-8538251
Homepage URL
Email yasukawa@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Nagoya City University Graduate School of Medicine
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
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
2015 Year 03 Month 23 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 03 Month 31 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2012 Year 11 Month 30 Day
Date of closure to data entry
2013 Year 11 Month 30 Day
Date trial data considered complete
2013 Year 11 Month 30 Day
Date analysis concluded
2014 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date
2015 Year 03 Month 22 Day
Last modified on
2015 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019582

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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