Anti-VEGFR Vaccine Therapy in Treating Patients With Neovascular Maculopathy

Age Related Macular Degeneration Clinical Trial

Official title:

Histocompatibility Leukocyte Antigen (HLA)-A*2402 and A*0201 Restricted Peptide Vaccine Therapy in Patients With Neovascular Maculopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00791570
• Other study ID #: 08062
• Status: Completed
• Phase: Phase 1
• First received: October 31, 2008
• Last updated: October 14, 2012
• Start date: October 2008
• Est. completion date: April 2012

Study information

• Verified date: October 2012
• Source: Osaka University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration
• Neovascular Maculopathy

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
Japan	Ophthalmology, Osaka University Medical School	Suita	Osaka

Sponsors (2)

Lead Sponsor	Collaborator
Osaka University	Human Genome Center, Institute of Medical Science, University of Tokyo

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	To evaluate immunological responses. INF-r production of monocytes from the patients after the peptide stimulation will be measured by ELISA.		3 month	No