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
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Drug: intraocular injections of bevacizumab||Phase 2 Phase 3|
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|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Subjects who have trabeculectomies with intraocular bevacizumab injection
Drug: intraocular injections of bevacizumab
intracameral and subconjunctival injections
Other Name: glaucoma filtering surgery
- 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.
- 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.
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
|Contact: Changwon Kee, M.D., Ph.D.||firstname.lastname@example.org|
|Contact: Wool Suh, M.D.||email@example.com|
|Korea, Republic of|
|Samsung Medical Center||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Changwon Kee, M.D., Ph.D. 82-2-3410-3564 firstname.lastname@example.org|
|Contact: Wool Suh, M.D. 82-2-3410-3564 email@example.com|
|Study Chair:||Changwon Kee, M.D., Ph.D||Samsung Medical Center|