UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy for maintenance of Patients With Neovascular Maculopathy
Title of the study (Brief title)	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	kohji Nishida
Organization	Osaka Unniversity Medical School
Division name	Ophthalmology
Address	2-2 Yamadaoka, Suita
TEL
Email

Public contact
Name of contact person	Motokazu Tsujikawa
Organization	Osaka University Medical School
Division name	Ophthalmology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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