Age Related Macular Degeneration, Neovascular Maculopathy
Conditions
Brief summary
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
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.
Interventions
BIOLOGICALVEGFR1 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.
Sponsors
Human Genome Center, Institute of Medical Science, University of Tokyo
Osaka University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of this trial will be assessed based on National Cancer Institute-Common Toxicity Criteria,(NCI-CTC) version3. In case grade 4 or more complications occur, we will report the case to the review board within 14 days. | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of the trail will be assessed by external judge board using fluorescent and ICG angiography and optical coherence tomography. The best corrected visual acuity will be measured before and 3 month after the trail. | 3 month |
| To evaluate immunological responses. INF-r production of monocytes from the patients after the peptide stimulation will be measured by ELISA. | 3 month |
Countries
Japan
Outcome results
None listed