Clinical trial NCT01310764: Trabeculectomy With Subconjunctival Bevacizumab Injection
Official title: Efficacy and Safety of Trabeculectomy With Subconjunctival Bevacizumab Versus Trabeculectomy With Mitomycin C.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: Intraocular pressure
Trabeculectomy
Mitomycin C
Bevacizumab
Lead sponsor: Rassoul Akram Hospital
Sponsor class: OTHER
First posted: 2011-03-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intraocular pressure.
timeFrame: 7-12 months
Secondary outcomes:
measure: Number of medications.
timeFrame: 7-12 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Rassoul Akram hospital, eye research center
Study officials:
References:
citation: 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.
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.