The Effect of Bevacizumab on the Trabeculectomy

Glaucoma Clinical Trial

— bevazicumab  

Official title:

The Effect of Intracameral and Subconjunctival Injections of Bevacizumab in Trabeculectomy With Antimetabolite

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01122966
• Other study ID #: 2009-01-033
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: April 15, 2010
• Last updated: May 25, 2010
• Start date: March 2010
• Est. completion date: March 2012

Study information

• Verified date: May 2010
• Source: Samsung Medical Center
• Contact: Changwon Kee, M.D., Ph.D.
• Phone: 82-2-3410-3564
• Email: ckee[@]skku.edu
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• glaucoma patients who have trabeculectomy

Exclusion Criteria:

• patients with the other ocular disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• intraocular injections of bevacizumab
intracameral and subconjunctival injections

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Grewal DS, Jain R, Kumar H, Grewal SP. Evaluation of subconjunctival bevacizumab as an adjunct to trabeculectomy a pilot study. Ophthalmology. 2008 Dec;115(12):2141-2145.e2. doi: 10.1016/j.ophtha.2008.06.009. Epub 2008 Aug 9. — View Citation

Li Z, Van Bergen T, Van de Veire S, Van de Vel I, Moreau H, Dewerchin M, Maudgal PC, Zeyen T, Spileers W, Moons L, Stalmans I. Inhibition of vascular endothelial growth factor reduces scar formation after glaucoma filtration surgery. Invest Ophthalmol Vis Sci. 2009 Nov;50(11):5217-25. doi: 10.1167/iovs.08-2662. Epub 2009 May 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraocular pressure	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.	on postoperative 1month	Yes
Secondary	intraocular pressure	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.	on postoperative 6months, 12months, 18months, 24months	Yes