Linda Rose1, Julia M Byrd, Yousuf Qaseem. 1. Department of Ophthalmology (L.R.), University of New Mexico Health Sciences Center, University of New Mexico, Albuquerque, NM; Department of Ophthalmology (J.M.B.), University of Utah Health Center, Salt Lake City, Utah; and School of Medicine (Y.Q.), University of New Mexico, Albuquerque, NM.
Abstract
IMPORTANCE: Currently the only treatment for recurrent pterygium is surgery. This is a phase 1 trial investigating ranibizumab as a medical treatment for recurrent pterygium. OBJECTIVE: To assess the safety and efficacy of subtenon Ranibizimab for recurrent pterygia. DESIGN: Subjects with recurrent pterygium received subtenon ranibizumab and were followed for 1 year. Safety parameters were measured. Photographs were taken and quantitatively analyzed to measure the short-term (2 months) and long-term (5-26 months) response to treatment. SETTING: University of New Mexico Eye Clinic. PARTICIPANTS: Eight subjects with recurrent pterygia. INTERVENTIONS: Subtenon delivery of 0.5 to 2 mg of ranibizumab, at day 0, month 1, and month 2. MAIN OUTCOME MEASURES: Safety parameters included visual acuity, intraocular pressure, and assessment of ocular surface. Efficacy was assessed by comparing photographs taken at day 0 with a short-term follow-up photograph taken at month 2 and a long-term follow-up image taken at the final patient visit (range 5-26 months). Quantitative analysis of photographs was performed to measure vascularity in the treated zone. RESULTS: Four subjects had an arrest of pterygium growth with a visual reduction in vascularity and a quantitative reduction in the area of vascularization (average vascularized area in short-term follow-up images was 51% of the baseline photos at day 0, and in the long-term photos was 36% of day 0). The other four subjects had a less marked reduction in their vascularity in the short-term photos (69% of their baseline photos). This resulted in two subjects withdrawing from the study early. Long-term quantitative analysis for the two remaining "nonresponders," who completed the study, showed an average vascularized area that was 71% of that in their baseline photos. The long-term photos in these subjects did not appear to have a clinically relevant difference from the short-term photos. CONCLUSIONS: In half of the subjects, subtenon ranibizumab appeared to arrest growth. Although the response is variable, this may warrant the drug's use when attempting to control growth of recurrent pterygia, and may prevent consecutive surgery for some patients.
IMPORTANCE: Currently the only treatment for recurrent pterygium is surgery. This is a phase 1 trial investigating ranibizumab as a medical treatment for recurrent pterygium. OBJECTIVE: To assess the safety and efficacy of subtenon Ranibizimab for recurrent pterygia. DESIGN: Subjects with recurrent pterygium received subtenon ranibizumab and were followed for 1 year. Safety parameters were measured. Photographs were taken and quantitatively analyzed to measure the short-term (2 months) and long-term (5-26 months) response to treatment. SETTING: University of New Mexico Eye Clinic. PARTICIPANTS: Eight subjects with recurrent pterygia. INTERVENTIONS: Subtenon delivery of 0.5 to 2 mg of ranibizumab, at day 0, month 1, and month 2. MAIN OUTCOME MEASURES: Safety parameters included visual acuity, intraocular pressure, and assessment of ocular surface. Efficacy was assessed by comparing photographs taken at day 0 with a short-term follow-up photograph taken at month 2 and a long-term follow-up image taken at the final patient visit (range 5-26 months). Quantitative analysis of photographs was performed to measure vascularity in the treated zone. RESULTS: Four subjects had an arrest of pterygium growth with a visual reduction in vascularity and a quantitative reduction in the area of vascularization (average vascularized area in short-term follow-up images was 51% of the baseline photos at day 0, and in the long-term photos was 36% of day 0). The other four subjects had a less marked reduction in their vascularity in the short-term photos (69% of their baseline photos). This resulted in two subjects withdrawing from the study early. Long-term quantitative analysis for the two remaining "nonresponders," who completed the study, showed an average vascularized area that was 71% of that in their baseline photos. The long-term photos in these subjects did not appear to have a clinically relevant difference from the short-term photos. CONCLUSIONS: In half of the subjects, subtenon ranibizumab appeared to arrest growth. Although the response is variable, this may warrant the drug's use when attempting to control growth of recurrent pterygia, and may prevent consecutive surgery for some patients.