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The Effect of Bevacizumab on the Trabeculectomy (bevazicumab)

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ClinicalTrials.gov Identifier: NCT01122966
Recruitment Status : Unknown
Verified May 2010 by Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : May 13, 2010
Last Update Posted : May 26, 2010
Sponsor:
Information provided by:
Samsung Medical Center

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
Glaucoma 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 Type : Interventional  (Clinical Trial)
Estimated 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 : March 2010
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Bevacizumab

Arm Intervention/treatment
trabeculectomy
Subjects who have trabeculectomies with intraocular bevacizumab injection
Drug: intraocular injections of bevacizumab
intracameral and subconjunctival injections
Other Name: glaucoma filtering surgery




Primary Outcome Measures :
  1. intraocular pressure [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • glaucoma patients who have trabeculectomy

Exclusion Criteria:

  • patients with the other ocular disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01122966


Contacts
Contact: Changwon Kee, M.D., Ph.D. 82-2-3410-3564 ckee@skku.edu
Contact: Wool Suh, M.D. 82-2-3410-3564 being111@hotmail.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Changwon Kee, M.D., Ph.D.    82-2-3410-3564    ckee@skku.edu   
Contact: Wool Suh, M.D.    82-2-3410-3564    being111@hotmail.com   
Sponsors and Collaborators
Samsung Medical Center
Investigators
Study Chair: Changwon Kee, M.D., Ph.D Samsung Medical Center

Publications:
Responsible Party: Changwon Kee, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01122966     History of Changes
Other Study ID Numbers: 2009-01-033
First Posted: May 13, 2010    Key Record Dates
Last Update Posted: May 26, 2010
Last Verified: May 2010

Keywords provided by Samsung Medical Center:
trabeculectomy

Additional relevant MeSH terms:
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents