UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017081 |
|---|---|
| Receipt number | R000019815 |
| Scientific Title | Comparison of intravitreal ranibizumab injection with or without tissue plasminogen activator in the treatment of type 2 choroidal neovascularization |
| Date of disclosure of the study information | 2015/04/10 |
| Last modified on | 2015/04/08 20:59:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison of intravitreal ranibizumab injection with or without tissue plasminogen activator in the treatment of type 2 choroidal neovascularization
Acronym
Effect of tissue plasminogen activator on type 2 choroidal neovascularization
Scientific Title
Comparison of intravitreal ranibizumab injection with or without tissue plasminogen activator in the treatment of type 2 choroidal neovascularization
Scientific Title:Acronym
Effect of tissue plasminogen activator on type 2 choroidal neovascularization
Region
| Japan |
Condition
Condition
neovascular age-related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Anti-vascular endothelial growth factor (VEGF) therapies can effectively suppress development and progression of choroidal neovascularization (CNV). However, they possess little ability to regress once-developed fibrovascular tissue. The purpose of this study is to evaluate the impacts of fibrinolysis with Tissue plasminogen activator (tPA) on type 2 CNV.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Best-corrected visual acuities (BCVAs)
Key secondary outcomes
Central retinal thickness
Macular volume
The ILM-RPE thickness at the thickest point of the subretinal fibrinous and/or fibrovascular tissues
Base
Study type
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 injection of tPA combined with intravitreal 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
Age related macular degeneration with type 2 choroidal neovascularization,
Key exclusion criteria
previous treatments involving laser photocoagulation or photodynamic therapy
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 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
Department of Ophthalmology and Visual Science
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2015 | Year | 04 | Month | 10 | 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
| 2010 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | 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
| 2015 | Year | 04 | Month | 08 | Day |
Last modified on
| 2015 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019815
