title: Phase I study of subconjunctival ranibizumab in patients with primary pterygium undergoing pterygium surgery.
abstract: OBJECTIVE
  To evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients with primary pterygium undergoing pterygium surgery with autograft placement.
  
  
  METHODS
  Prospective, open-label pilot study.
  
  
  METHODS
  
  
  
  METHODS
  Single-center, academic practice.
  
  
  METHODS
  Ten patients with primary pterygia.
  
  
  METHODS
  Subconjunctival ranibizumab (0.5 mg/0.05 mL) administered at the limbus, adjacent to pterygium either 3 days prior to surgery (Group 1, n = 5) or at the time of surgery (Group 2, n = 5). Patients prospectively followed for 6 months after injection.
  
  
  METHODS
  Safety and tolerability of subconjunctival ranibizumab as determined by patient reporting, clinical examination, and masked observer interpretation of slit-lamp photographs.
  
  
  RESULTS
  The median age at presentation was 59 years (range 33 to 71 years); 60% of patients were male. Five patients were randomly assigned to be injected with 0.05 mg ranibizumab via subconjunctival injection 3 days prior to surgery; an additional 5 patients were injected with ranibizumab at the time of surgery. All 10 patients tolerated the injection well. The conjunctival autograft remained intact in the 9 patients whose grafts were secured with sutures. There was dehiscence of the autograft in the 1 patient whose graft was secured with fibrin glue. No other safety concerns arose after 6 months of follow-up. Three pterygium recurrences were noted at 6 months (all patients in Group 1). All remaining patients had a normal surgical bed appearance.
  
  
  CONCLUSIONS
  The data from this small pilot study suggest that 1 subconjunctival injection of ranibizumab in conjunction with pterygium surgery is well tolerated.
authors.affiliation: Bascom Palmer Eye Institute, University of Miami, Miller School of Medicine, Miami, Florida 33136, USA.
authors.forename: Anat
authors.initials: A
authors.lastname: Galor
authors.forename: Sonia H
authors.initials: SH
authors.lastname: Yoo
authors.forename: Fernanda V R
authors.initials: FV
authors.lastname: Piccoli
authors.forename: Artur J
authors.initials: AJ
authors.lastname: Schmitt
authors.forename: Victoria
authors.initials: V
authors.lastname: Chang
authors.forename: Victor L
authors.initials: VL
authors.lastname: Perez
mesh_terms: D000328:Adult; D000368:Aged; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D003131:Combined Modality Therapy; D003228:Conjunctiva / Q000187:drug effects* / Q000601:surgery; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007267:Injections; D008297:Male; D008875:Middle Aged; D013508:Ophthalmologic Surgical Procedures; D010865:Pilot Projects; D011446:Prospective Studies; D011625:Pterygium / Q000188:drug therapy* / Q000601:surgery*; D000069579:Ranibizumab; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors
chemical_list: D020533:Angiogenesis Inhibitors; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D042461:Vascular Endothelial Growth Factor A; D000069579:Ranibizumab