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Catherine M Birt, Javiera Compan, Sana Muhsen, Tze Lai, Christoph Kranemann; Use of Bevacizumab following trabeculectomy surgery: A prospective, randomized, controlled trial. Invest. Ophthalmol. Vis. Sci. 2014;55(13):3154.
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To compare the effectiveness of postoperative adjunctive use of Bevacizumab in altering the outcome of trabeculectomy in terms of sustained IOP (intra ocular pressure) lowering and reduction of bleb vascularization and fibrosis.
60 patients with various types of glaucoma undergoing first-time trabeculectomy with Mitomycin-C were recruited and randomized. 40 patients have completed the study with 1 year follow-up. On the second post-operative day, 1.25 mg of Bevacizumab was administered subconjunctivally in Group 1 (n=22) and 0.1 mL of sterile saline in Group 2 (n=18), adjacent to the bleb.
At one year, there was a mean IOP reduction of 39% in Group 1 and 43% in Group 2. 13% of the patients in Group 1 and 27% in Group 2 had to resume glaucoma drops to reach the target pressure. The blebs were categorized using the Indiana Bleb Appearance Grading Scale. At one year 59% of blebs were considered optimal in Group 1 and 55% in Group 2. 5-fluorouracil (5-FU) needling to the bleb was required in 59% of patients in Group 1, and 33% in Group 2. At one year, 63% of patients were considered a complete success in Group 1 and 27% in control Group 2, however the sample size wasn’t sufficient to produce a statistically significant p-value (p=.111). 16 % of cases were considered clinical failures in Group 2 and no failures were found in Group 1. The rate of complications was not statistically significant between groups.
No statistically significant differences were found when comparing the baseline pressure and final pressure between both groups. The bleb aspect was optimal in more patients in Group 1, however this was not related to a lower intraocular pressure or less requirement of 5-FU needling. The number of patients considered a complete success was higher in Group 1, but this was not statistically significant. The higher rate of success in Group 1 can be explained by the 5-FU needlings performed during the 6 week postoperative period, which is not considered a criterion for failure, and this group showed a lower percentage of patients using glaucoma drops at 1 year. A bigger sample size is needed in order to examine whether the differences between the treatment groups is statistically significant.
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