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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006372
Receipt No. 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

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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
Email

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
Email moto@ophthal.med.osaka-u.ac.jp

Sponsor
Institute Department of Ophthalmology, Osaka University Medical School
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007562

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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