Purchase this article with an account.
M. J. Pro, A. K. Sawchyn, P. Ichhpujani, S. Wizov, M. R. Moster, G. L. Spaeth; Intraoperative Ranibizumab versus Mitomycin-C in Primary Trabeculectomy-A Pilot Study. Invest. Ophthalmol. Vis. Sci. 2010;51(13):619.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
To assess the safety, tolerability, and efficacy of intra-operative Ranibizumab in primary trabeculectomy.
A prospective, open-label study comparing subjects randomized to intraoperative Mitomycin-C (MMC ) 0.4 mg/mL or Ranibizumab 0.5 mL (0.1 mg/mL) during a primary trabeculectomy is being conducted. LogMAR visual acuity, intraocular pressure (IOP), number of glaucoma drops, bleb grading according to the Indiana Bleb Appearance Grading Scale (IBAGS), complications, and subjective complaints are recorded at day 1, week 2, and months 1, 3, and 6 postoperatively. The Ranibizumab and MMC arms are compared using the Student’s t-test.
Nineteen subjects (10 Ranibizumab, 9 MMC) have been enrolled. All Ranibizumab subjects have completed follow up through 6 months. In the MMC group, 1 subject has completed follow up through 2 weeks, 2 subjects through 1 month, 1 subject through 3 months, and 5 subjects through 6 months. The average preoperative IOP was 25.4+/-12.8mmHg for Ranibizumab subjects and 17.0+/-3.9mmHg for MMC subjects (p=0.04). There was no statistically significant difference between the groups in mean acuity, subjective complaints (pain, foreign body sensation, tearing, itching, dry eye), or bleb appearance at any time point (p>0.05). One case of hypotony was seen in each group in the first 2 weeks postoperatively. Mean IOP was comparable between the groups at week 2 (14.4+/-7.7mmHg, vs. 11.6 +/- 8.8mmHg, p=0.38) but higher in the Ranibizumab group at month 1 (21.4+/-5.3mmHg vs. 11.0+/-3.1mmHg, p=0.0007) and month 3 (13.72 +/- 4.8mmHg vs. 8.67 +/-1.8mmHg, p=0.012). Mean IOP was similar between the groups at 6 months postoperatively (10.8+/-3.1mmHg vs. 10.3+/-2.1mmHg, p=0.29), but 4 of 6 Ranibizumab subjects were on anti-glaucoma medications compared to none of the MMC subjects. As of 6 months postoperatively, 3 subjects in the Ranibizumab group have required additional surgery compared to no patients in the MMC group.
Ranibizumab is a safe and well tolerated adjunctive medication in primary trabeculectomy. Data regarding efficacy should be interpreted cautiously given the small sample size, interim nature of analysis, and differences in baseline patient characteristics.
Clinical Trial: :
This PDF is available to Subscribers Only