Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mitomycin C | Sham Comparator | Those with trabeculectomy and intraoperative application of mitomycin C. |
|
| Bevacizumab | Active Comparator | Those with trabeculectomy and adjunctive intraoperative subconjunctival injection of bevacizumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trabeculectomy | Procedure | Both groups underwent trabeculectomy ,but in active group bevacizumab was used and in sham group mitomycin c was used during the surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of medications. | Number of pre and post operative medications were recorded and compared in each post operative visits. | 7-12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rassoul Akram hospital, eye research center | Tehran | Tehran Province | 14455-364 | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18692246 | Background | 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. | |
| 19182254 | Background | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014130 | Trabeculectomy |
| ID | Term |
|---|---|
| D018463 | Filtering Surgery |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided