| Titel | FRO - Can peroperative bevacizumab (Avastin) improve trabeculectomy outcome? A prospective, randomized, placebo-controlled study |
| Doel | Glaucoma surgery fails in 30% due to excessive scar formation of the constructed channel. Our group found that vascular endothelial growth factor (VEGF) is upregulated in the aqueous humor of glaucoma patients and postoperatively in a rabbit model for trabeculectomy, that VEGF stimulates fibroblast proliferation in vitro whereas bevacizumab can inhibit their growth, and that a single peroperative intracameral injection of bevacizumab improves the surgical outcome of trabeculectomy in a rabbit model. Based on these findings, we set up a clinical trial to study the potential of bevacizumab as an anti-scarring agent after trabeculectomy. |
| Methodes | This is a prospective, randomized, placebo-controlled, double-blinded experimental study. The effect of peroperative administration of 50 µl of bevacizumab (25mg/ml) on intraocular pressure, bleb characteristics, as well as number of postoperative IOP-lowering medications and surgical interventions is investigated. Patients with primary open-angle glaucoma (POAG) and normal tension glaucoma (NTG) who are scheduled for primary trabeculectomy are included. |
| Resultaten | Inclusions started on April 2009. Based on a priori calculations we need to include 124 patients. The inclusions will be accomplished in September 2010. |
| Conclusie | This study will provide evidence on effectiveness and safety of single administration of bevacizumab during trabeculectomy to reduce the risk of surgical failure, avoiding or reducing the need for long-term medication use or secondary surgical intervention. |
| Naam | VANDEWALLE |
| Initialen | E |
| Instituut | ULZ |
| Stad | Leuven |
| Naam | Zeyen |
| Initialen | T |
| Instituut | UZL |
| Stad | Leuven |
| Naam | Spielberg |
| Initialen | I |
| Instituut | Dep of ophthalmology |
| Stad | Rotterdam |
| Naam | Stalmans |
| Initialen | I |
| Instituut | UZL |
| Stad | Leuven |