Abstract
Purpose :
To evaluate the effect of adjunctive intraoperative intravitreal bevacizumab injection on trabeculectomy bleb function and structure during the first postoperative 12 months.
Methods :
Single centre double-blinded randomised, placebo-controlled trial on 131 patients with glaucoma requiring trabeculectomy.
Intervention: Patients were subjected to a standardised trabeculectomy procedure augmented with onlay MMC 0.04%, and standardised follow-up protocol. Subjects were randomised to receive intraoperative intravitreal injection of either bevacizumab (1.25mg in 0.05ml) or placebo (balanced salt solution; BSS, 0.05ml).
The primary outcome was defined as ‘complete success’ if intraocular pressure (IOP) remained less than a predefined target IOP without the requirement of topical IOP lowering medication, or ‘qualified success’ if additional topical IOP lowering medication was required to meet the predefined target IOP threshold. Secondary outcomes included IOP, requirement for subsequent bleb needling, number of IOP lowering medications, and bleb morphology based on assessment of the trabeculectomy bleb using the Moorfields Bleb Grading Scheme.
Results :
Of 131 patients randomised to bevacizumab (n=65) or placebo (n=66), 128 patients completed 12 months of follow up. At one year, 6% of the bevacizumab group failed the definition of complete success, compared with 17% of those in the placebo group (P=0.015). In addition, 2% of the bevacizumab group failed the definition of qualified success, compared with 10% of those in the placebo group (P=0.033). Within the placebo group, IOP and the requirement for bleb needling was higher at one month (P<0.05). Usage of IOP lowering medication was higher at 6-months (P<0.05) and 12-months (P<0.05). Blebs in the bevacizumab group were larger in the central extent (P<0.001), total extent (P<0.01) and height (P<0.001) at one month compared with the placebo group. There was no significant difference in complications between the bevacizumab and placebo groups.
Conclusions :
Bevacizumab given as a single intravitreal dose during trabeculectomy surgery results in improved surgical success as 12 months, with a significant reduction in the need for additional medication and bleb needling to achieve target IOP. Furthermore, this intervention results in blebs which are larger and less inflamed.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.