title: 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.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Glaucoma Services, Aravind Eye Hospital, Pondicherry, India. drsunny1980@gmail.com
authors.forename: Sabyasachi
authors.initials: S
authors.lastname: Sengupta
authors.forename: Rengaraj
authors.initials: R
authors.lastname: Venkatesh
authors.forename: Ravilla D
authors.initials: RD
authors.lastname: Ravindran
mesh_terms: D000368:Aged; D000477:Alkylating Agents / Q000008:administration & dosage* / Q000009:adverse effects; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects; D000068258:Bevacizumab; D002386:Cataract / Q000150:complications; D002908:Chronic Disease; D003131:Combined Modality Therapy; D003228:Conjunctiva / Q000187:drug effects*; D005260:Female; D015812:Glaucoma, Angle-Closure / Q000150:complications / Q000601:surgery; D005902:Glaucoma, Open-Angle / Q000150:complications / Q000601:surgery; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage* / Q000009:adverse effects; D056687:Off-Label Use; D018918:Phacoemulsification; D010865:Pilot Projects; D014065:Tonometry, Ocular; D014130:Trabeculectomy; D017211:Treatment Failure; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects
chemical_list: D000477:Alkylating Agents; D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab; D016685:Mitomycin