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Evelien Vandewalle, Thierry Zeyen, Leigh Spielberg, Ingeborg Stalmans; The Effect Of Peroperative Bevacizumab (Avastin) On Trabeculectomy Outcome: A Prospective, Randomized, Double-blinded, Placebo-controlled Trial. Invest. Ophthalmol. Vis. Sci. 2011;52(14):625.
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To investigate the effect of peroperative intracameral bevacizumab in terms of clinical outcomes following trabeculectomy in patients with either primary open-angle glaucoma (POAG) or normal tension glaucoma (NTG).
Between April 2009 until November 2010, 134 consecutive, medically uncontrolled glaucoma patients who were scheduled for first-time trabeculectomy were included in this prospective, randomized, placebo-controlled, double-blinded study. Patients were divided into POAG and NTG groups, which were then randomized to 1 of 2 groups: 50 µl bevacizumab (25mg/ml) or placebo (NaCl). Patients with NTG also received mitomycin C. The target IOP was <18 mmHg for POAG and <14 mmHg for NTG patients.Absolute success was defined as meeting or exceeding the target IOP at the 6-month follow-up period without IOP-lowering medications or postoperative interventions except bleb massage or suturolysis. Qualitative success was defined as meeting the target IOP with IOP-lowering medications or postoperative surgical interventions. Failure was defined as requiring a second trabeculectomy to reach the target IOP.
As of the end of November 2010, 87 patients had reached the 6-month follow-up point, of whom 45 received bevacizumab and 42 received placebo. Absolute success in this group was 85% in the bevacizumab group and 69% in the placebo group. Qualified success was 13% in the bevacizumab group and 21% in the placebo group. Failure occurred in 2% of the bevacizumab group and 10% of the placebo group. Needlings were performed in 7% of the bevacizumab group and39% of the placebo group.
A single intracameral injection of bevacizumab at the end of trabeculectomy was associated with increased absolute success rates and reduced need for postoperative interventions in order to reach the target IOP. By May 2011, the complete group will have reached the 6-month follow-up point and the results will be presented with p-values based on a priori calculations of patient inclusion numbers.
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