NCT00815594

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 30, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

December 30, 2008

Status Verified

December 1, 2008

Enrollment Period

3 months

First QC Date

December 29, 2008

Last Update Submit

December 29, 2008

Conditions

Bleb VascularityConjunctival Scarring

Keywords

blebvascular changebevacizumabtrabeculectomyBleb vascularity associated with increased scarring activityConjunctival scarring finally leads to the obstruction of the fistula tract created by the filtering surgerythe recombinant human anti-VEGF antibody could inhibit angiogenesis of conjunctiva.

Outcome Measures

Primary Outcomes (1)

  • bleb vascular change

    one day, one week, one month

Interventions

bevacizumabDRUG

0.05ml, 1.25mg

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Glaucoma patients after trabeculectomy whose bleb is hyperaemia

You may not qualify if:

  • Affected eye has normal IOP
  • Not allergic with Avastin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongren hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Blister

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Skin Diseases, VesiculobullousSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Liu Xuan, M.D.

    An ophthalmologist in Tongren hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 29, 2008

First Posted

December 30, 2008

Study Start

December 1, 2008

Primary Completion

March 1, 2009

Study Completion

May 1, 2009

Last Updated

December 30, 2008

Record last verified: 2008-12

Locations

CN(1)