Anti-VEGFR Vaccine Therapy in Treating Patients With Neovascular Maculopathy

This study has been completed.
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Osaka University
ClinicalTrials.gov Identifier:
NCT00791570
First received: October 31, 2008
Last updated: October 14, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention Phase
Neovascular Maculopathy
Age Related Macular Degeneration
Biological: VEGFR1 and VEGFR2
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Histocompatibility Leukocyte Antigen (HLA)-A*2402 and A*0201 Restricted Peptide Vaccine Therapy in Patients With Neovascular Maculopathy

Resource links provided by NLM:


Further study details as provided by Osaka University:

Primary Outcome Measures:
  • 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. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • To evaluate immunological responses. INF-r production of monocytes from the patients after the peptide stimulation will be measured by ELISA. [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: October 2008
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A 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.
Other Names:
  • VEGFR1
  • VEGFR2
  • AMD

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.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791570

Locations
Japan
Ophthalmology, Osaka University Medical School
Suita, Osaka, Japan, 565
Sponsors and Collaborators
Osaka University
Human Genome Center, Institute of Medical Science, University of Tokyo
Investigators
Study Chair: Kohji Nishida, MD, PhD Chair of Ophthalmology, Osaka University Medical School
  More Information

No publications provided

Responsible Party: Yasuo Tano, Department of Ophthalmology, Osaka University Medical School
ClinicalTrials.gov Identifier: NCT00791570     History of Changes
Other Study ID Numbers: 08062
Study First Received: October 31, 2008
Last Updated: October 14, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on October 29, 2014