Bleb Vascularity Change After Subconjunctival Injection B... | NCT00815594

Studies
Bleb Vascularity Change After Subconjunctival Injection Bevacizumab

NCT00815594

Sponsor

Capital Medical University

Status

Unknown status

Last Update Posted

Dec 30, 2008Estimated

Enrollment

30Estimated

Phase

Phase 4

Conditions

Bleb Vascularity
Conjunctival Scarring

Interventions

bevacizumab

Countries

China

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

Dec 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Mar 2009Estimated

Completion Date

May 2009Estimated

First Submitted Date

Dec 29, 2008

First Submission Date that Met QC Criteria

Dec 29, 2008

First Posted Date

Dec 30, 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

Dec 29, 2008

Last Update Posted Date

Dec 30, 2008Estimated

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 occurrence of conjunctival scarring finally leads to the obstruction of the fistula tract created by the filtering surgery. Vascular endothelial growth factor is thought to be a key role in the formation of conjunctival scar, which play a pivotal role in the wound-healing process. So it seems that the recombinant human anti-VEGF antibody could inhibit angiogenesis, and reduce the conjunctival vascular formation in the wound-healing process after glaucoma filtering surgery.

Detailed Description

Not provided

Conditions Module

Conditions

Bleb Vascularity
Conjunctival Scarring

Keywords

bleb
vascular change
bevacizumab
trabeculectomy
Bleb vascularity associated with increased scarring activity
Conjunctival scarring finally leads to the obstruction of the fistula tract created by the filtering surgery
the recombinant human anti-VEGF antibody could inhibit angiogenesis of conjunctiva.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Name	Type	Description	Arm Group Labels	Other Names
bevacizumab	Drug	0.05ml, 1.25mg

Measure	Description	Time Frame
bleb vascular change		one day, one week, one month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Glaucoma patients after trabeculectomy whose bleb is hyperaemia

Exclusion Criteria:

Affected eye has normal IOP
Not allergic with Avastin

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Liu Xuan, M.D.	An ophthalmologist in Tongren hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tongren hospital		Beijing	Beijing Municipality	100730	China

Condition Browse Module

MeSH Terms

ID	Term
D001768	Blister

Ancestor Terms

ID	Term
D012872	Skin Diseases, Vesiculobullous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D020763	Pathological Conditions, Anatomical

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068258	Bevacizumab

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided