Prevention of Recurrent Pterygium with Topical Bevacizumab 0.05% Eye Drops: A Randomized Controlled Trial
Ngamjit Kasetsuwan, Usanee Reinprayoon, Vannarut Satitpitakul*Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand; E-mail: [email protected]
บทคัดย่อ
Purpose: We assessed the efficacy and tolerability of topical bevacizumab 0.05% when used as an adjunctive therapy after excision of primary pterygia.
Methods: This randomized double-masked study included 22 patients (22 eyes) with primary pterygia who underwent pterygium surgery with the use of the bare sclera technique. After pterygium excision, 22 patients were randomized to receive the topical bevacizumab 0.05% (12 eyes) or the placebo (10 eyes) with the use of the block of four randomization method. Topical bevacizumab and placebo were applied in the respective groups 4 times daily for 3 months. Follow-up evaluations for recurrence by slit-lamp photography were conducted once monthly. Ocular and systemic adverse events were assessed every 2 weeks during the 3 months of treatment. The slit-lamp photographs were masked and analyzed. The primary and secondary outcomes were the differences in the pterygial recurrence rates between the groups and adverse events at 3 months, respectively. Corneal recurrence was defined as recurrent fibrovascular tissue invading the cornea; conjunctival recurrence was defined as either recurrent vessels or fibrous tissue in the excised area without corneal invasion.
Findings: All 22 patients completed follow-up at 3 months after the start of the trial medications. After 3 months of treatment, 1 patient (8.33%) and 3 patients (30.00%) from the bevacizumab and placebo groups, respectively, had a corneal recurrence. No significant (P = 0.293) differences were found between the groups as determined by Fisher's exact test. However, conjunctival and corneal recurrences were found in 4 (33.33%) and 9 (90.00%) patients, respectively, in the bevacizumab and placebo groups, a difference that reached significance (P = 0.01). No significant adverse events developed.
Implications: Topical bevacizumab, as an adjunctive treatment after pterygium excision, was well tolerated. The trend for recurrence was lower in the topical bevacizumab group.
ที่มา
Clinical Therapeutics ปี 2558, October
ปีที่: 37 ฉบับที่ 10 หน้า 2347-2351
คำสำคัญ
Pterygium, recurrence pterygium, antivascular endothelial growth factor, bevacizumab, pterygium surgery