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This prospective, double-masked, randomized, placebo-controlled study by Landers et al. compared one-year surgical success following fornix-based trabeculectomy with mitomycin- C, with and without intraoperative intravitreal bevacizumab, an anti-vascular endothelial growth factor (anti-VEGF) medication, by two surgeons at a single institution. Postoperative management was at surgeon discretion.
Trial design included a sample-size calculation to detect significant differences between the cohorts (n = 131) with 98% retention at one year. Target IOP was standardized per the methodology of the Collaborative Initial Glaucoma Treatment Study.
At 12 months, the bevacizumab group demonstrated a higher rate of 'complete success' (94% vs 83%; target IOP without medications), lower IOP, and larger blebs with less vascularity compared to controls. 'Qualified success', requiring medications, was achieved in 98% vs 90% (treatment vs controls). The treatment group underwent fewer bleb needling only during the early post-op period (< 1 month) and required fewer medications following six-months post-op. There was a trend (p = 0.08) towards higher rates of bleb avascularity and Tenon cysts in the treatment group, a concern of prior studies with adjunct anti-VEGF treatment.1-3
A small proportion of patients had prior trabeculectomy surgery, concurrent phacoemulsification, angle-closure glaucoma and other secondary glaucomas including uveitic and pseudoexfoliation. This was potentially problematic with disparities following the randomization process for some diagnoses. However, the authors addressed this issue with separate analyses revealing no significant impact on reported outcomes. As most subjects had POAG/NTG (n = 82, 63%), subgroup analysis indicated 100% 'complete success' in the bevacizumab group vs 89% of controls. Notably, the demographic of this Australia-based study is predominantly (98.5%) of European descent, limiting extrapolation of these results for patients of non-European ancestry.
This study demonstrates improved success of trabeculectomy with intraoperative intravitreal anti-VEGF therapy
This study demonstrates improved success of trabeculectomy with intraoperative intravitreal anti-VEGF therapy, exhibiting longer duration of effect compared to subconjunctival or intracameral use. This one-year data is promising, while also highlighting a possible increased risk of avascular blebs and Tenon's cysts. Although long-term bleb survival and results on patients of diverse ethnic backgrounds will be required to realize a shift in practice patterns, this prospective, randomized study represents another step of improved success of our gold-standard glaucoma surgery.