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Anti-VEGFR Vaccine Therapy in Treating Patients With Neovascular Maculopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00791570
Recruitment Status : Completed
First Posted : November 14, 2008
Last Update Posted : October 16, 2012
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Osaka University

Study Description
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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

Condition or disease Intervention/treatment Phase
Neovascular Maculopathy Age Related Macular Degeneration Biological: VEGFR1 and VEGFR2 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2008
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791570


Locations
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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
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Study Chair: Kohji Nishida, MD, PhD Chair of Ophthalmology, Osaka University Medical School
More Information
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Responsible Party: Yasuo Tano, Department of Ophthalmology, Osaka University Medical School
ClinicalTrials.gov Identifier: NCT00791570    
Other Study ID Numbers: 08062
First Posted: November 14, 2008    Key Record Dates
Last Update Posted: October 16, 2012
Last Verified: October 2012
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases