PURPOSE: The current standard adjunctive agent used in primary trabeculectomy is mitomycin C (MMC), but it is associated with well known complications. The objective of this study is to test the feasibility of the anti-vascular endothelial growth factor (anti-VEGF) agent ranibizumab for adjunctive use instead of MMC (0.4 mg/ml). MATERIALS AND METHODS: A prospective, randomized open label study of 24 consecutive patients undergoing primary trabeculectomy at the Wills Eye Institute Glaucoma Service from March 2008 through February 2010 was conducted. Twenty-four eyes were included in the study and clinical outcomes were examined. RESULTS: There were no significant differences in baseline demographic or clinical characteristics between the ranibizumab and MMC groups. Nine of the 12 ranibizumab patients completed the 1 year study. Three subjects required tube shunt surgery and were removed from the study. Eleven of 12 MMC patients completed the study (one underwent hip surgery and was lost to follow-up). Mean intra-ocular pressure (IOP) was significantly higher in the ranibizumab arm at 1 month (p = 0.002). Bleb extent was significantly less in the ranibizumab arm at 6 months (p = 0.006). Patients in the ranibizumab arm required more hypotensive medication at month 3 (p = 0.011). CONCLUSIONS: Although there was no IOP difference or difference in medication use between the two treatment groups at one year, more patients in the ranibizumab group required additional glaucoma surgery during the study period.
RCT Entities:
PURPOSE: The current standard adjunctive agent used in primary trabeculectomy is mitomycin C (MMC), but it is associated with well known complications. The objective of this study is to test the feasibility of the anti-vascular endothelial growth factor (anti-VEGF) agent ranibizumab for adjunctive use instead of MMC (0.4 mg/ml). MATERIALS AND METHODS: A prospective, randomized open label study of 24 consecutive patients undergoing primary trabeculectomy at the Wills Eye Institute Glaucoma Service from March 2008 through February 2010 was conducted. Twenty-four eyes were included in the study and clinical outcomes were examined. RESULTS: There were no significant differences in baseline demographic or clinical characteristics between the ranibizumab and MMC groups. Nine of the 12 ranibizumabpatients completed the 1 year study. Three subjects required tube shunt surgery and were removed from the study. Eleven of 12 MMCpatients completed the study (one underwent hip surgery and was lost to follow-up). Mean intra-ocular pressure (IOP) was significantly higher in the ranibizumab arm at 1 month (p = 0.002). Bleb extent was significantly less in the ranibizumab arm at 6 months (p = 0.006). Patients in the ranibizumab arm required more hypotensive medication at month 3 (p = 0.011). CONCLUSIONS: Although there was no IOP difference or difference in medication use between the two treatment groups at one year, more patients in the ranibizumab group required additional glaucoma surgery during the study period.