Trabeculectomy With Subconjunctival Bevacizumab Injection

Glaucoma Clinical Trial

Official title:

Efficacy and Safety of Trabeculectomy With Subconjunctival Bevacizumab Versus Trabeculectomy With Mitomycin C.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01310764
• Other study ID #: 971
• Status: Completed
• Phase: N/A
• First received: March 7, 2011
• Last updated: March 28, 2011
• Start date: April 2009
• Est. completion date: July 2010

Study information

• Verified date: April 2009
• Source: Rassoul Akram Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the safety and efficacy of bevacizumab as an adjunctive treatment to trabeculectomy in open angle glaucoma patients and to compare this new drug to the most commonly used anti-scarring agent, mitomycin C.

Description:

The most common surgical technique for controlling the intraocular pressure in glaucoma patients is trabeculectomy.In this surgery, internal cavity of the eye is connected by a fistula like openings to subconjunctival space. The main cause of failure in trabeculectomy is excessive postoperative conjunctival scarring at the site of fistula, which is related to severity of conjunctival vascularization, tortuousity of vessel, and fibroblast migration and proliferation. At the time of surgery most surgeons use mitomycin C, which is an antimitotic and antifibrotic agent, to improve the results of the procedure. Although this agent is very effective, but is not without complication. The most significant and sight threatening complications are low intraocular pressure and endophthalmitis. Therefore investigations are going on to find a much safer and effective agents. Bevacizumab is a monoclonal antibody against vascular endothelial factor (VEGF). VEGF is an important vasculogenic and fibrogenic factor with a prominent role in wound healing.Bevacizumab is widely used in ophthalmology and has a promising effect in treatment of neovascularization in conjunctiva, cornea and retina. There are limited animal and human case series regarding the effect of this agent in trabeculectomy. In this study the investigators are trying, in addition to evaluating the efficacy and safety of this agent in result of trabeculectomy, compare this agent with mitomycin C.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Uncontrolled Open angle glaucoma.

• Glaucoma patients who are non-compliant to medical treatment.

• Progressive glaucoma despite of medical treatment.

• Follow-up of at least 6 months after surgery

Exclusion Criteria:

• History of prior ocular surgery.

• Pregnancy or breast feeding.

• Age < 18 years.

• History of ocular surface infection in recent two weeks.

• History of systemic thrombo-embolic events.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Procedure:
• Trabeculectomy
Both groups underwent trabeculectomy ,but in active group bevacizumab was used and in sham group mitomycin c was used during the surgery.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Rassoul Akram hospital, eye research center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Rassoul Akram Hospital

Country where clinical trial is conducted

Iran, Islamic 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

Memarzadeh F, Varma R, Lin LT, Parikh JG, Dustin L, Alcaraz A, Eliott D. Postoperative use of bevacizumab as an antifibrotic agent in glaucoma filtration surgery in the rabbit. Invest Ophthalmol Vis Sci. 2009 Jul;50(7):3233-7. doi: 10.1167/iovs.08-2441. Epub 2009 Jan 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure.	Pre and post operative intraocular pressures are measured with Goldmann applanation tonometer at each time point visits and the measurement were compared between both groups.	7-12 months	No
Secondary	Number of medications.	Number of pre and post operative medications were recorded and compared in each post operative visits.	7-12 months	No