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Michael J. Pro, Kathryn Freidl, Andrea Sawchyn, Marlene R. Moster, Sheryl Wizov; Intraoperative Ranibizumab versus Mitomycin-C in Primary Trabeculectomy_A Pilot Study. Invest. Ophthalmol. Vis. Sci. 2011;52(14):621.
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To assess safety, tolerability, and efficacy of intra-operative Ranibizumab in primary trabeculectomy.
A prospective, open-label study comparing subjects randomized to intraoperative Mitomycin-C (MMC ) 0.4mg/mL or Ranibizumab 0.5mL (0.1mg/mL) during a primary trabeculectomy was conducted. Visual acuity (VA), intraocular pressure (IOP), number of glaucoma drops, bleb grading using the Indiana Bleb Appearance Grading Scale (IBAGS), complications, and subjective complaints were recorded through 12 months. The Ranibizumab and MMC arms were compared using the Student’s t-test.
Twenty-four subjects were enrolled. Twenty-three patients had completed follow-up at 6 months, and 18 subjects at 1 year. Preoperative parameters including VA and IOP were similar. At 1 month, IOP was higher in Ranibizumab vs. MMC (23.7 +/- 6.53 mmHg vs. 11.6 +/- 3.7 mmHg, p=0.000093). At 6 months, IOP was higher in Ranibizumab vs. MMC (15.16 +/- 6.53 mmHg vs. 10 +/- 3.7 mmHg, p=0.016023). At 3 months, Lucentis subjects were on an average of 1.2 drops and MMC subjects were on average of 0.3 drops (p=0.019119). At no other time point was drop usage significantly different. In the Ranibizumab group 3 subjects required additional glaucoma surgery (tube shunt), as compared with none in the MMC arm. These patients were withdrawn from the study and considered primary trabeculectomy failures. At the one year follow-up there was no difference in IOP in the remaining Ranibizumab subjects versus MMC subjects. (14.3+/-6.5 vs. 11.5+/-3.7 mmHg, p=0.18) Most subjective criteria were similar with a few minor exceptions. At POM #1, patients who received MMC complained of more itchiness (p=0.0103).
Patients who received adjunctive Ranibizumab during primary trabeculectomy had higher eye pressure and required additional glaucoma surgery compared with those who received MMC. It appears that the effect of Ranibizimab in preventing episcleral fibrosis may dissipate. It is possible that serial post-operative Ranibizumab injections could prevent trabeculectomy failure seen in this pilot study. Serial post-operative Ranibizumab injections could be considered as a direction for future studies.
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