UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006372 |
|---|---|
| Receipt number | R000007562 |
| Scientific Title | Phase II study of Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy for maintenance of Patients With Neovascular Maculopathy |
| Date of disclosure of the study information | 2011/09/20 |
| Last modified on | 2017/05/08 17:49:45 |
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Basic information
Public title
Phase II study of Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy for maintenance of Patients With Neovascular Maculopathy
Acronym
Anti-VEGFR Vaccine Therapy in Treating Patients With Neovascular Maculopathy(Phase II)
Scientific Title
Phase II study of Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy for maintenance of Patients With Neovascular Maculopathy
Scientific Title:Acronym
Anti-VEGFR Vaccine Therapy in Treating Patients With Neovascular Maculopathy(Phase II)
Region
| Japan |
Condition
Condition
Neovascular Maculopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy
To reduce the intervention of Rabinismab(Lucentis) intra vitreous injection using with anti-VEGFR vaccine
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy
To reduce the intervention of Rabinismab(Lucentis) intra vitreous injection using with anti-VEGFR vaccine. (2years)
Key secondary outcomes
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
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Vaccine |
Interventions/Control_1
According HLA typing, patients with A*0201 will be treated with vaccine therapy in addition ot Rabinismab (Lucentis) therapy
Interventions/Control_2
According HLA typing, patients with A*2402 will be treated with vaccine therapy in addition ot Rabinismab (Lucentis) therapy
Interventions/Control_3
The other patients will be performed standard Rabinismab (Lucentis) therapy.
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Neovascular Maculopathy including Age Related Macular Degeneration.
2.Frequent Rabinismab (Lucentis) injection will be necesarry
Key exclusion criteria
Pregnancy(woman of childbearing potential:Refusal or inability to use effective means of contraception)
Breast feeding
Active or uncontrolled infection
Unhealed external wound
Concurrent treatment with steroids or immunosuppressing agent
Uncontrolled brain and/or intraspinal lesion(s)
Decision of unsuitableness by principal investigator or physician-in-charge.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | kohji Nishida |
Organization
Osaka Unniversity Medical School
Division name
Ophthalmology
Zip code
Address
2-2 Yamadaoka, Suita
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motokazu Tsujikawa |
Organization
Osaka University Medical School
Division name
Ophthalmology
Zip code
Address
TEL
Homepage URL
moto@ophthal.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Osaka University Medical School
Institute
Department
Personal name
Funding Source
Organization
Research Grant form NHLW(Japan)
Organization
Division
Category of Funding Organization
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
大阪大学医学部付属病院、滋賀医科大学付属病院、香川大学医学部付属病院、関西医科大学付属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 20 | 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
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | 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
| 2011 | Year | 09 | Month | 20 | Day |
Last modified on
| 2017 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007562
