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Ingeborg Stalmans, Thierry Zeyen, Tine Van Bergen, Leigh Spielberg, Lieve Moons, Werner Spileers, Evelien Vandewalle; A Single Intracameral Bevacizumab Administration Improves Trabeculectomy Outcome: A Randomized Placebo-controlled Trial. Invest. Ophthalmol. Vis. Sci. 2012;53(14):2505.
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To investigate the effect of a single, preoperative, intracameral administration of bevacizumab (Avastin®) in terms of clinical outcome following trabeculectomy in patients with either primary open-angle glaucoma (POAG) or normal tension glaucoma (NTG).
Between April 2009 and November 2010, 144 consecutive, medically uncontrolled glaucoma patients who were scheduled for primary trabeculectomy were included in this prospective, randomized, double-blinded and placebo-controlled study. Patients were divided into POAG and NTG groups, which were then randomized to receive 50 µl of either bevacizumab (25 mg/ml) or placebo (balanced salt solution (BSS)) in the anterior chamber peroperatively. Patients with NTG also received mitomycin C. The target intraocular pressure (IOP) range was between 6 and 18 mmHg for POAG and between 6 and 14 mmHg for NTG patients. Absolute success was defined as meeting the target IOP at 6 month follow-up visit without IOP-lowering medications or postoperative interventions. Qualified success was defined as meeting the target IOP at month 6 with or without either IOP-lowering medications and/or postoperative surgical interventions. Bleb photographs were recorded in a subgroup (n=22) of the patients and graded according to the Moorfields bleb grading system by 2 masked observers.
Of the 144 included patients, 141 reached the 6-month follow-up point, of whom 70 received bevacizumab and 71 received placebo. Three patients were lost to follow-up. Absolute success in the bevacizumab group was 83% compared to 59% in the placebo group (p=0.003, Odds Ratio (OR) 3.3, confidence interval (CI) 1.4-7.9). Qualified success was 99% in the bevacizumab group versus 94% in the placebo group (not significant, OR 4, CI 0.3-201). Needlings were significantly less frequent in the bevacizumab group compared to the placebo group, respectively in 11% versus 32% (p=0.004). Complication rates were comparable in both groups. The Moorfields bleb scores were significantly different between the treatment (sub-) groups: peripheral bleb area (p=0.04), peripheral bleb vascularity (p=0.002) and non-bleb related peripheral bleb vascularity (p=0.01) at month 6.
A single intracameral administration of bevacizumab at the end of trabeculectomy was associated with increased absolute success rates, reduced need for postoperative interventions in order to reach the target IOP and more diffuse blebs with a lower degree of vascularity.
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