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


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 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


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

Value
https://center6.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