bevazicumab: The Effect of Bevacizumab on the Trabeculectomy

Sponsor
Samsung Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT01122966
Collaborator
(none)
40
1
1
24
1.7

Study Details

Study Description

Brief Summary

The investigators plan to evaluate the additive effect of intracameral and subconjunctival injections of bevacizumab in trabeculectomies with other antimetabolites.

Condition or Disease Intervention/Treatment Phase
  • Drug: intraocular injections of bevacizumab
Phase 2/Phase 3

Detailed Description

Glaucoma filtration surgery is routinely utilized to control intraocular pressure in glaucomatous patients. It reduces IOP by creating a fistula between the anterior chamber and the subconjunctival space with a filtering bleb. Increased wound healing response affects the function and morphology of the filtering bleb, and wound healing involves a series of biological events beginning with hemostasis.

Corticosteroids and antifibrosis agents such as mitomycin C and 5-fluorouracil have been employed in trabeculectomy to delay wound healing and hence to improve the success rate of surgery by inhibiting inflammation and fibroblastic activity, and the use of these antiscarring agents is generally believed to improve the success rate of trabeculectomy.But this rate decreased with passing time and thus was not perfect.

Vascular endothelial growth factor is a pivotal stimulator of angiogenesis because its binding to VEGF receptors has been demonstrated to promote endothelial cell migration and proliferation in wound healing.Therefore, anti-VEGF agents may potentially modulate wound healing following glaucoma filtration surgery.

The principal objective of this study was to evaluate the additive effect of intracameral and subconjunctival injections of bevacizumab in trabeculectomy.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Intracameral and Subconjunctival Injections of Bevacizumab in Trabeculectomy With Antimetabolite
Study Start Date :
Mar 1, 2010
Anticipated Primary Completion Date :
Mar 1, 2011
Anticipated Study Completion Date :
Mar 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Other: trabeculectomy

Subjects who have trabeculectomies with intraocular bevacizumab injection

Drug: intraocular injections of bevacizumab
intracameral and subconjunctival injections
Other Names:
  • glaucoma filtering surgery
  • Outcome Measures

    Primary Outcome Measures

    1. intraocular pressure [on postoperative 1month]

      Intraocular pressure is planned to measure when the patient visit the clinic. All intraocular pressure measurements is acquired by glaucoma specialists, using a slitlamp-mounted Goldmann applanation tonometer.

    Secondary Outcome Measures

    1. intraocular pressure [on postoperative 6months, 12months, 18months, 24months]

      Intraocular pressure is planned to measure when the patient visit the clinic. All intraocular pressure measurements is acquired by glaucoma specialists, using a slitlamp-mounted Goldmann applanation tonometer.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • glaucoma patients who have trabeculectomy
    Exclusion Criteria:
    • patients with the other ocular disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Samsung Medical Center Seoul Korea, Republic of

    Sponsors and Collaborators

    • Samsung Medical Center

    Investigators

    • Study Chair: Changwon Kee, M.D., Ph.D, Samsung Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01122966
    Other Study ID Numbers:
    • 2009-01-033
    First Posted:
    May 13, 2010
    Last Update Posted:
    May 26, 2010
    Last Verified:
    May 1, 2010
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 26, 2010