Bevacizumab Treatment and Retinal Vessel Monitoring (BevaRet)

January 20, 2016 updated by: Technische Universität Dresden

Analysis of Retinal Vessel Reaction and Monitoring of Circulation Parameters During Bevacizumab Therapy

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

Study Overview

Status

Completed

Conditions

Intervention / 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

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Autonomic lab (ANF)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Cancer patients with first bevacizumab treatment

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diameter of retinal vessels and dynamic vessel reaction
Time Frame: Measurements before and after administration
Measurements before and after administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Baroreflex sensitivity, heart frequence variability, reaction to handgrip test
Time Frame: Measurements before and after administration
Measurements before and after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Investigators

  • Principal Investigator: Tjalf Ziemssen, MD, Neurological University Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

August 20, 2008

First Submitted That Met QC Criteria

August 20, 2008

First Posted (Estimate)

August 22, 2008

Study Record Updates

Last Update Posted (Estimate)

January 21, 2016

Last Update Submitted That Met QC Criteria

January 20, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-ANF1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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