Intravitreal Bevacizumab Improves Trabeculectomy Survival at 3 Years: Long-term Follow-up from The 'Bevacizumab in Trabeculectomy Study'.

Objective

To evaluate the effect of a single intraoperative dose of intravitreal bevacizumab (Avastin) on surgical success following trabeculectomy with mitomycin-C (MMC) over three years.

Design

Single centre, parallel, double-blinded randomised, placebo-controlled trial.

Setting

A single ophthalmic outpatient referral centre within a tertiary teaching hospital.

Participants

Patients requiring primary or redo-trabeculectomy or phaco-trabeculectomy for progressing glaucoma.

Intervention

Patients were randomised to a single intraoperative intravitreal injection of Avastin (1.25mg in 0.05ml) or placebo (balanced salt solution 0.05ml).

MAIN OUTCOME MEASURE: The primary outcome was treatment success which was defined by 'complete success' when intraocular pressure (IOP) remained less than a predefined target IOP without the requirement of topical medication, or 'qualified success' where topical medication was required to meet the predefined target IOP threshold.

Results

From a total of 131 patients randomised to Bevacizumab (Avastin; n=65) or placebo (n=66), 111 patients completed 36-months of follow up (85%). At 36 months, trabeculectomy survival was higher in the Bevacizumab cohort (hazard ratio [complete success] = 0.17, P=0.015; [qualified success] =0.07, P=0.03). Within the placebo cohort, the requirement for topical therapy was higher at 3-months (P=0.008, 6-months (P=0.009) and 12-months (P=0.007), and 36-months (P<0.005).

Conclusion

Bevacizumab given as a single intravitreal dose during trabeculectomy with MMC resulted in improved surgical success at 36-months post-operatively.