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Anti-VEGFR Vaccine Therapy in Treating Patients With Neovascular Maculopathy

NCT ID: NCT00791570

Last Updated: 2012-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-04-30

Brief Summary

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The purpose of this study is to evaluate the safety and time to progression of HLA-A\*2402 or A\*0201 restricted epitope peptides VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in patients with Neovascular Maculopathy, including Age Related Macular Degeneration

Detailed Description

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VEGF receptor 1 and 2 are essential targets to pathogenic angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and vivo. According to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides. Patients will be vaccinated once a week for 12 weeks. On each vaccination day, VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection. In the study, our primary aim is to evaluate the safety and tolerability of these peptide vaccine. The second aim is evaluate the immunological and clinical response of this vaccine therapy.

Conditions

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Neovascular Maculopathy Age Related Macular Degeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

VEGFR1 and VEGFR2

Intervention Type BIOLOGICAL

Biological: VEGFR1 and VEGFR2 Patients will be vaccinated once a week for 12 weeks. On each vaccination day, VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.

Interventions

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VEGFR1 and VEGFR2

Biological: VEGFR1 and VEGFR2 Patients will be vaccinated once a week for 12 weeks. On each vaccination day, VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.

Intervention Type BIOLOGICAL

Other Intervention Names

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VEGFR1 VEGFR2 AMD

Eligibility Criteria

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Inclusion Criteria

* Neovascular Maculopathy including Age Related Macular Degeneration.
* Resistant against PDT or Anti VEGF therapy or Patient disagree with these therapies.
* with HLA-A\*2402 or A\*0201

Exclusion Criteria

* Pregnancy(woman of childbearing potential:Refusal or inability to use effective means of contraception) Breastfeeding 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
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Human Genome Center, Institute of Medical Science, University of Tokyo

OTHER

Sponsor Role collaborator

Osaka University

OTHER

Sponsor Role lead

Responsible Party

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Department of Ophthalmology, Osaka University Medical School

Principal Investigators

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Kohji Nishida, MD, PhD

Role: STUDY_CHAIR

Chair of Ophthalmology, Osaka University Medical School

Locations

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Ophthalmology, Osaka University Medical School

Suita, Osaka, Japan

Site Status

Countries

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Japan

Other Identifiers

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08062

Identifier Type: -

Identifier Source: org_study_id