Anti-VEGFR Vaccine Therapy in Treating Patients With Neovascular Maculopathy

Osaka University

Status and phase: Completed; Phase 1

Conditions: Age Related Macular Degeneration; Neovascular Maculopathy

Treatments: Biological: VEGFR1 and VEGFR2

Study type: Interventional

Funder types: Other

Identifiers

NCT00791570

08062

Details and patient eligibility

About

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

Full description

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.

Enrollment: 17 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

A

Experimental group

Treatment:

Biological: VEGFR1 and VEGFR2