Bevacizumab Treatment and Retinal Vessel Monitoring | NCT00740168

Studies
Bevacizumab Treatment and Retinal Vessel Monitoring

NCT00740168

Sponsor

Technische Universität Dresden

Status

Completed

Last Update Posted

Jan 21, 2016Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Cancer

Interventions

bevacizumab treatment

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Dec 2008Actual

Completion Date

Apr 2009Actual

First Submitted Date

Aug 20, 2008

First Submission Date that Met QC Criteria

Aug 20, 2008

First Posted Date

Aug 22, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2016

Last Update Posted Date

Jan 21, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TG		Bevacizumab treatment group with metastasized cancer	Drug: bevacizumab treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bevacizumab treatment	Drug	single infusion 10 mg/kg	TG	Avastin

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Cancer patients with first bevacizumab treatment

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tjalf Ziemssen, MD	Neurological University Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Autonomic lab (ANF)		Dresden	Saxony	01307	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23668549	Derived	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.

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins