The Effect of Therapy With Bevacizumab in Chronic Central... | NCT00864773

Studies
The Effect of Therapy With Bevacizumab in Chronic Central Serous Chorioretinopathy

NCT00864773

Sponsor

Hallym University Medical Center

Status

Unknown status

Last Update Posted

Mar 19, 2009Estimated

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Central Serous Chorioretinopathy

Interventions

intravitreal injection with anterior paracentesis

Countries

Not provided

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Mar 2010Estimated

Completion Date

Mar 2010Estimated

First Submitted Date

Mar 18, 2009

First Submission Date that Met QC Criteria

Mar 18, 2009

First Posted Date

Mar 19, 2009Estimated

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

Mar 18, 2009

Last Update Posted Date

Mar 19, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The pathophysiology of central serous chorioretinopathy remains controversial. traditional treatment is laser photocoagulation or photodynamic therapy.Recently Bevacizumab (Avastin, Genetech),an antibody to vascular endothelial growth factor (VEGF),has known antipermeability properties and therefore may theoretically reverse the changes seen in central serous chorioretinopathy. The aim of this study is To investigate concentrations of growth factors and inflammatory cytokines and to report the effect of therapy with bevacizumab in eyes with central serous chorioretinopathy

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intravitreal injection with anterior paracentesis	Procedure	0.1cc Aqueous humor samples were taken each time an intravitreal injection of bevacizumab (2.5 mg in 0.1 ml)		Bevacizumab (Avastin, Genetech) an antibody to vascular endothelial growth factor (VEGF)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Concentrations of growth factors and inflammatory cytokines in Aqueous humor		at baseline

Secondary Outcomes

Measure	Description	Time Frame
Central macular thickness at optical coherence tomography		baseline, 1 month, 3 months, 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with a diagnosis of central serous chorioretinopathy
Idiopathic neurosensory retinal elevation demonstrated by optical coherent tomography
Presence of focal leaks at the level of the RPE on fluorescein angiography

Exclusion Criteria:

Known side effects of systemic bevacizumab administration
Have a significant cardiovascular or thromboembolic history or were pregnant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Type	Date	Date Unknown
Release	Aug 3, 2010
Unrelease		Yes
Release	Aug 4, 2010
Reset	Aug 31, 2010
Release	Aug 31, 2010
Reset	Sep 22, 2010
Release	Apr 25, 2011
Reset	May 18, 2011
Release	Jun 22, 2011
Reset	Jul 20, 2011

Submission Tracking

Estimated Results First Submitted Date

Aug 3, 2010

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Aug 3, 2010		Yes
Aug 4, 2010

Condition Browse Module

MeSH Terms

ID	Term
D056833	Central Serous Chorioretinopathy

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D058449	Intravitreal Injections
D000068258	Bevacizumab

Ancestor Terms

ID	Term
D056965	Injections, Intraocular
D007267	Injections
D004333	Drug Administration Routes
D004358	Drug Therapy

Browse Leaves

Not provided

Browse Branches

Not provided