The Effect of Bevacizumab on the Trabeculectomy (bevazicumab)
Recruitment status was: Recruiting
|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|
- 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.
- 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.
|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)|
Subjects who have trabeculectomies with intraocular bevacizumab injection
Drug: intraocular injections of bevacizumab
intracameral and subconjunctival injections
Other Name: glaucoma filtering surgery
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01122966
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of|
|Study Chair:||Changwon Kee, M.D., Ph.D||Samsung Medical Center|