Can peroperative bevacizumab (AvastinTM) improve trabeculectomy outcome? A prospective, randomized, placebo-controlled study
| Autor: | Ingeborg Stalmans, Thierry Zeyen, L Spielberg, Evelien Vandewalle |
|---|---|
| Rok vydání: | 2010 |
| Předmět: |
Intraocular pressure
medicine.medical_specialty genetic structures Bevacizumab business.industry medicine.medical_treatment Placebo-controlled study Glaucoma General Medicine medicine.disease eye diseases Surgery Clinical trial Ophthalmology Normal tension glaucoma Glaucoma surgery Medicine Trabeculectomy sense organs business medicine.drug |
| Zdroj: | Acta Ophthalmologica. 88 |
| ISSN: | 1755-375X |
| DOI: | 10.1111/j.1755-3768.2010.3153.x |
| Popis: | Purpose 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. Methods 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. Results Inclusions started on April 2009 and are still ongoing. Based on a priori calculations we need to include 124 patients. We already included 97 patients, 54 of which are POAG and 43 are NTG patients. By the end of September the majority will have ended the study. The preliminary results of this group will be presented at EVER. Conclusion 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Plný text