The Effect of Bevacizumab on the Trabeculectomy (bevazicumab)
Recruitment status was Recruiting
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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 |
- 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.
| 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 |
Inclusion Criteria:
- glaucoma patients who have trabeculectomy
Exclusion Criteria:
- patients with the other ocular disease
Contacts and Locations| 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 |
| 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 | |
| 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:
|
Glaucoma Ocular Hypertension Eye Diseases Antimetabolites Bevacizumab Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013