NCT00740168

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

January 21, 2016

Status Verified

January 1, 2016

Enrollment Period

1.6 years

First QC Date

August 20, 2008

Last Update Submit

January 20, 2016

Conditions

Cancer

Keywords

bevacizumabcancer

Outcome Measures

Primary Outcomes (1)

  • Diameter of retinal vessels and dynamic vessel reaction

    Measurements before and after administration

Secondary Outcomes (1)

  • Baroreflex sensitivity, heart frequence variability, reaction to handgrip test

    Measurements before and after administration

Study Arms (1)

TG

Bevacizumab treatment group with metastasized cancer

Drug: bevacizumab treatment

Interventions

bevacizumab treatmentDRUG

single infusion 10 mg/kg

Also known as: Avastin, ATC code: L01XC07, CAS Registry Number:216974-75-3, VEGF-inhibitor
TG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cancer patients with first bevacizumab treatment

You may qualify if:

  • patients who wish and need bevacizumab treatment for underlying disease

You may not qualify if:

  • 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
  • intake of vasoactive drugs like AT-1 or glitazone
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Autonomic lab (ANF)

Dresden, Saxony, 01307, Germany

Location

Related Publications (1)

  • Reimann M, Folprecht G, Haase R, Trautmann K, Ehninger G, Reichmann H, Ziemssen F, Ziemssen T. Anti-Vascular endothelial growth factor therapy impairs endothelial function of retinal microcirculation in colon cancer patients - an observational study. Exp Transl Stroke Med. 2013 May 13;5(1):7. doi: 10.1186/2040-7378-5-7.

    PMID: 23668549DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Tjalf Ziemssen, MD

    Neurological University Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2008

First Posted

August 22, 2008

Study Start

May 1, 2007

Primary Completion

December 1, 2008

Study Completion

April 1, 2009

Last Updated

January 21, 2016

Record last verified: 2016-01

Locations

DE(1)