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NCT00740168 Clinical Trial

Bevacizumab Treatment and Retinal Vessel Monitoring

Cancer Clinical Trial

— BevaRet  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00740168
Other study ID # B-ANF1
Secondary ID
Status Completed
Phase N/A
First received August 20, 2008
Last updated January 20, 2016
Start date May 2007
Est. completion date April 2009

Study information
Verified date January 2016
Source Technische Universität Dresden
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

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

Description:

By monitoring different vessel and circulation parameters (e.g. dynamic retinal vessel analyzer) the study will clarify the potential hemodynamic effects of bevacizumab.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date April 2009
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• bevacizumab treatment
single infusion 10 mg/kg

Locations
Country Name City State
Germany Autonomic lab (ANF) Dresden Sachsen

Sponsors (1)
Lead Sponsor Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diameter of retinal vessels and dynamic vessel reaction Measurements before and after administration Yes
Secondary Baroreflex sensitivity, heart frequence variability, reaction to handgrip test Measurements before and after administration Yes
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