Safety and efficacy of using off-label bevacizumab versus mitomycin C to prevent bleb failure in a single-site phacotrabeculectomy by a randomized controlled clinical trial

J Glaucoma. 2012 Sep;21(7):450-9. doi: 10.1097/IJG.0b013e31821826b2.

Abstract

Purpose: To analyze the safety and efficacy of bevacizumab (1.25 mg/0.05 mL) versus 0.03% mitomycin C (MMC) for preventing bleb failure in patients undergoing single-site phacotrabeculectomy for primary open-angle glaucoma or chronic angle-closure glaucoma.

Materials and methods: Thirty-eight consecutive patients with visually significant cataract and coexistent primary open-angle glaucoma or chronic angle-closure glaucoma were randomized into 3 groups. One group received conventional 0.03% MMC (n=13); the second group received 3 subconjunctival injections of bevacizumab (1.25 mg in 0.05 mL) (n=13); and the third group received bevacizumab soaked in sponges (1.25 mg in 0.05 mL) (n=12) intraoperatively on the sclera. Patients were followed up for 6 months. The primary outcome measure was treatment success and bleb morphology in the study eye at 6-month follow-up.

Results: All 3 groups showed significant reduction in mean intraocular pressure at 1 week after treatment, which was maintained at 6 months. However, the subconjunctival bevacizumab group had 90% patients with complete success as opposed to 60% in each of the other 2 groups (P=0.04). In both bevacizumab groups, bleb vascularity increased progressively over the 6-month follow-up. One patient in the subconjunctival bevacizumab group showed a local conjunctival necrosis.

Conclusion: In this pilot study with a small number of subjects, short-term outcomes suggest that subconjunctival bevacizumab is equally effective in reducing intraocular pressure with a better safety profile compared with MMC in the dosing schedule studied. However, bevacizumab soaked in a sponge appears to have no advantages over MMC. Subconjunctival bevacizumab may be a useful agent for improving success and for limiting scar tissue after phacotrabeculectomy.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Alkylating Agents / administration & dosage*
  • Alkylating Agents / adverse effects
  • Angiogenesis Inhibitors / administration & dosage*
  • Angiogenesis Inhibitors / adverse effects
  • Antibodies, Monoclonal, Humanized / administration & dosage*
  • Antibodies, Monoclonal, Humanized / adverse effects
  • Bevacizumab
  • Cataract / complications
  • Chronic Disease
  • Combined Modality Therapy
  • Conjunctiva / drug effects*
  • Female
  • Glaucoma, Angle-Closure / complications
  • Glaucoma, Angle-Closure / surgery
  • Glaucoma, Open-Angle / complications
  • Glaucoma, Open-Angle / surgery
  • Humans
  • Intraocular Pressure / physiology
  • Male
  • Middle Aged
  • Mitomycin / administration & dosage*
  • Mitomycin / adverse effects
  • Off-Label Use
  • Phacoemulsification*
  • Pilot Projects
  • Tonometry, Ocular
  • Trabeculectomy*
  • Treatment Failure
  • Treatment Outcome
  • Wound Healing / drug effects

Substances

  • Alkylating Agents
  • Angiogenesis Inhibitors
  • Antibodies, Monoclonal, Humanized
  • Bevacizumab
  • Mitomycin