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Bevacizumab Treatment and Retinal Vessel Monitoring (BevaRet)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Dresden University of Technology.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Dresden University of Technology
ClinicalTrials.gov Identifier:
NCT00740168
First received: August 20, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  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:

MedlinePlus related topics: Cancer
Drug Information available for: Bevacizumab
U.S. FDA Resources

Further study details as provided by Dresden University of Technology:

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

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

Estimated Enrollment: 20
Study Start Date: May 2007
Estimated Study Completion Date: April 2009
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00740168

Contacts
Contact: Tjalf Ziemssen, MD +49-351-458-7450 Tjalf.Ziemssen@uniklinikum-dresden.de

Locations
Germany
Autonomic lab (ANF) Recruiting
Dresden, Sachsen, Germany, 01307
Contact: Silke Prieur     +49-351-458-3859     Silke.Prieur@neuro.med.tu-dresden.de    
Principal Investigator: Tjalf Ziemssen, MD            
Sponsors and Collaborators
Dresden University of Technology
Investigators
Principal Investigator: Tjalf Ziemssen, MD Neurological University Clinic
  More Information

No publications provided

Responsible Party: Dr. Tjalf Ziemssen, Autonomic lab (ANF)
ClinicalTrials.gov Identifier: NCT00740168     History of Changes
Other Study ID Numbers: B-ANF1
Study First Received: August 20, 2008
Last Updated: August 20, 2008
Health Authority: Germany: Ethics Commission

Keywords provided by Dresden University of Technology:
bevacizumab
cancer

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

ClinicalTrials.gov processed this record on May 23, 2013