Bevacizumab Treatment and Retinal Vessel Monitoring (BevaRet)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00740168
First received: August 20, 2008
Last updated: January 20, 2016
Last verified: January 2016
  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 ] [ 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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT00740168     History of Changes
Other Study ID Numbers: B-ANF1 
Study First Received: August 20, 2008
Last Updated: January 20, 2016
Health Authority: Germany: Ethics Commission

Keywords provided by Technische Universität Dresden:
bevacizumab
cancer

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

ClinicalTrials.gov processed this record on February 04, 2016