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Bevacizumab Treatment and Retinal Vessel Monitoring (BevaRet)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00740168
First Posted: August 22, 2008
Last Update Posted: January 21, 2016
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.
Information provided by (Responsible Party):
Technische Universität Dresden
  Purpose
Bevacizumab might influence the dynamic vessel function after being administered intravenously.

Condition Intervention
Cancer Drug: bevacizumab treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Retinal Vessel Reaction and Monitoring of Circulation Parameters During Bevacizumab Therapy

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • Diameter of retinal vessels and dynamic vessel reaction [ Time Frame: Measurements before and after administration ]

Secondary Outcome Measures:
  • Baroreflex sensitivity, heart frequence variability, reaction to handgrip test [ Time Frame: Measurements before and after administration ]

Enrollment: 20
Study Start Date: May 2007
Study Completion Date: April 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
TG
Bevacizumab treatment group with metastasized cancer
Drug: bevacizumab treatment
single infusion 10 mg/kg
Other Names:
  • Avastin
  • ATC code: L01XC07
  • CAS Registry Number:216974-75-3
  • VEGF-inhibitor

Detailed Description:
By monitoring different vessel and circulation parameters (e.g. dynamic retinal vessel analyzer) the study will clarify the potential hemodynamic effects of bevacizumab.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Cancer patients with first bevacizumab treatment
Criteria

Inclusion Criteria:

  • patients who wish and need bevacizumab treatment for underlying disease

Exclusion Criteria:

  • previous bevacizumab treatment
  • known eye disease, eye surgery or eye trauma in history
  • myopia >-2.0 dpt
  • hyperopia > +2.0 dpt.
  • relevant media opacity of the lens
  • acute heart disease, ischemic insult, proven coronary heart disease
  • cardiac arrhythmia or vessel anomalies
  • seizure disorder or episode in history
  • migraine
  • treatment with corticosteroids within 4 weeks before study inclusion
  • intake of vasoactive drugs like AT-1 or glitazone
  • pregnancy
  Contacts and Locations
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): NCT00740168


Locations
Germany
Autonomic lab (ANF)
Dresden, Sachsen, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
Investigators
Principal Investigator: Tjalf Ziemssen, MD Neurological University Clinic
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT00740168     History of Changes
Other Study ID Numbers: B-ANF1
First Submitted: August 20, 2008
First Posted: August 22, 2008
Last Update Posted: January 21, 2016
Last Verified: January 2016

Keywords provided by Technische Universität Dresden:
bevacizumab
cancer

Additional relevant MeSH terms:
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents