UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016870 |
|---|---|
| Receipt number | 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 23:07:52 |
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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
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
yasukawa@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019582
