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Bevacizumab Treatment and Retinal Vessel Monitoring (BevaRet)

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ClinicalTrials.gov Identifier: NCT00740168
Recruitment Status : Completed
First Posted : August 22, 2008
Last Update Posted : January 21, 2016
Sponsor:
Information provided by (Responsible Party):
Technische Universität Dresden

Brief Summary:
Bevacizumab might influence the dynamic vessel function after being administered intravenously.

Condition or disease Intervention/treatment
Cancer Drug: bevacizumab treatment

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.

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Retinal Vessel Reaction and Monitoring of Circulation Parameters During Bevacizumab Therapy
Study Start Date : May 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources

Group/Cohort Intervention/treatment
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



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

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


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

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

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 Posted: August 22, 2008    Key Record Dates
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