Anti-VEGFR Vaccine Therapy in Treating Patients With Neovascular Maculopathy

Phase 1

Completed

• Conditions: Neovascular Maculopathy; Age Related Macular Degeneration
• Interventions: Biological: VEGFR1 and VEGFR2

• Registration Number: NCT00791570
• Lead Sponsor: Osaka University

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-31
• Study First Submitted QC: 2008-11-13
• Study First Posted: 2008-11-14
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-14
• Last Update Posted: 2012-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	VEGFR1 and VEGFR2	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ophthalmology, Osaka University Medical School; 🇯🇵 Suita, Osaka, Japan