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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

Tracking Information
First Submitted Date  ICMJE October 31, 2008
First Posted Date  ICMJE November 14, 2008
Last Update Posted Date October 16, 2012
Study Start Date  ICMJE October 2008
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2008)
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anti-VEGFR Vaccine Therapy in Treating Patients With Neovascular Maculopathy
Official Title  ICMJE Histocompatibility Leukocyte Antigen (HLA)-A*2402 and A*0201 Restricted Peptide Vaccine Therapy in Patients With Neovascular Maculopathy
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Neovascular Maculopathy
  • Age Related Macular Degeneration
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: A
Intervention: Biological: VEGFR1 and VEGFR2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 14, 2012)
17
Original Estimated Enrollment  ICMJE
 (submitted: November 13, 2008)
20
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00791570
Other Study ID Numbers  ICMJE 08062
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yasuo Tano, Department of Ophthalmology, Osaka University Medical School
Study Sponsor  ICMJE Osaka University
Collaborators  ICMJE Human Genome Center, Institute of Medical Science, University of Tokyo
Investigators  ICMJE
Study Chair: Kohji Nishida, MD, PhD Chair of Ophthalmology, Osaka University Medical School
PRS Account Osaka University
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP