Phase I study of subconjunctival ranibizumab in patients with primary pterygium undergoing pterygium surgery.

Purpose To evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients with primary pterygium undergoing pterygium surgery with autograft placement. Design Prospective, open-label pilot study. Methods Setting: Single-center, academic practice. Study Population: Ten patients with primary pterygia. bservational Procedure: 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. Main Outcome Measures: 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.