Assessing safety and success after using bevacizumab, 5-fluorouracil or placebo in primary trabeculectomy. A prospective randomized placebo controlled 1-year follow-up study

Abstract

Purpose The aim of this study was to determine whether glaucoma patients after trabeculectomy could benefit more from subconjunctival injections of bevacizumab than 5-FU or placebo. Methods and results Fifty-one eyes of 51 patients were recruited for primary MMC (0.2 mg/mL for 1 min) augmented trabeculectomy. 17 patients were randomly assigned to receive 1.25 mg (0.05 mL) of bevacizumab augmentation, 21 patients were assigned to receive 0.1 mL of 50 mg/mL 5-FU and 13 patients were assigned to a control group receiving a normal saline injection as a placebo. Initial recruitment included 58 patients, but seven patients had to be excluded from the study for various reasons. Postoperative follow up of IOP and bleb characteristics was carried out at 1 day, 1 week, 3 weeks, 6 weeks, 6 months and 1 year after surgery. All analyses where carried out by two masked clinicians. IOP reduction was statistically significant (p < 0.05) across all three groups between baseline visit and final 1-year postoperative visit. There was no significant difference of the final average IOP values between the three groups. Bleb evaluation was made using the Moorfields bleb grading system (MBGS) after 1 year follow up. Central bleb area was statistically greater in the Bevacizumab group when compared with the 5-FU group but not with the placebo group. The vascularity of the central bleb was significantly different between the groups with the Bevacizumab group showing the least vascularity. Vascularity of the peripheral bleb was also decreased in the Bevacizumab group when compared with the placebo group but not with the 5-FU group. Conclusion The 12-month IOP results showed no significant differences between the groups of patients after Bevacizumab, 5-FU or placebo to augment primary MMC enhanced trabeculectomy. However, by the analysis of bleb morphology there was a significant difference in terms of central bleb area and vascularity.