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. OBSERVATIONAL 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.
Galor, A; Yoo, SH; Piccoli, FVR; Schmitt, AJ; Chang, V; Perez, VL
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