The Effect of Bevacizumab on the Trabeculectomy (bevazicumab)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01122966
First received: April 15, 2010
Last updated: May 25, 2010
Last verified: May 2010
  Purpose

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


Condition Intervention Phase
Glaucoma
Drug: intraocular injections of bevacizumab
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Intracameral and Subconjunctival Injections of Bevacizumab in Trabeculectomy With Antimetabolite

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • intraocular pressure [ Time Frame: on postoperative 1month ] [ Designated as safety issue: Yes ]
    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:
  • intraocular pressure [ Time Frame: on postoperative 6months, 12months, 18months, 24months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 40
Study Start Date: March 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
trabeculectomy
Subjects who have trabeculectomies with intraocular bevacizumab injection
Drug: intraocular injections of bevacizumab
intracameral and subconjunctival injections
Other Name: glaucoma filtering surgery

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • glaucoma patients who have trabeculectomy

Exclusion Criteria:

  • patients with the other ocular disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Changwon Kee, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01122966     History of Changes
Other Study ID Numbers: 2009-01-033
Study First Received: April 15, 2010
Last Updated: May 25, 2010
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
trabeculectomy

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

ClinicalTrials.gov processed this record on October 23, 2014