A single intravitreal bevacizumab dose improved trabeculectomy survival at 3 years

Design

Single-centre, double-masked, placebo-controlled randomised trial

Population

131 patients having trabeculectomy or phacotrabeculectomy with mitomycin C

Primary outcome

Surgical success (complete and qualified) at 36 months

Effect

Complete success HR 0.17 (P = .002); qualified success HR 0.07 (P = .03)

This single-centre, double-masked, placebo-controlled randomised trial enrolled 131 patients needing primary or repeat trabeculectomy or phacotrabeculectomy with mitomycin C for progressing glaucoma. They received one intraoperative intravitreal injection of bevacizumab 1.25 mg or balanced salt solution. The three-year results were published in May.

Of 131, 111 completed 36 months. Survival was higher with bevacizumab for both complete success (no drops needed; hazard ratio 0.17, P = .002) and qualified success (with drops; HR 0.07, P = .03). The placebo group needed drops more often at every time point from 3 to 36 months.

The rationale is that bevacizumab damps the VEGF-driven wound healing that scars the bleb. Bevacizumab is inexpensive and widely used intravitreally in India, so the intervention is practical. It comes from a single centre with moderate numbers, and the hazard ratios are very large for a single injection, which a multicentre trial should confirm. Intravitreal injection carries its own small risks, including endophthalmitis.

• Consider a single intraoperative intravitreal bevacizumab injection with mitomycin C trabeculectomy.
• Discuss the added small risks of an intravitreal injection when consenting.
• Use standard intravitreal asepsis and dosing (1.25 mg in 0.05 mL), as in the trial.
• Continue standard postoperative bleb management; bevacizumab is an adjunct, not a substitute.
• Watch for multicentre confirmation before treating it as standard.

Why it matters

A cheap, single-step addition may extend the life of the operation that most often fails from scarring.

Don't overread it

This is a single-centre trial of 131 patients; the size of the effect needs multicentre confirmation.

The statistics, in plain English

A hazard ratio of 0.17 means the rate of failure was about one-sixth that of placebo over three years — a very large effect. With 131 patients and one centre, effects this large are often smaller when repeated elsewhere. 85% completed follow-up, which is good for a three-year surgical trial.

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