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T. Y. Tai, M. Pro, J. Myers, L. J. Katz, G. L. Spaeth, M. R. Moster; Needle Bleb Revision With Bevacizumab for Failing Filtration Blebs. Invest. Ophthalmol. Vis. Sci. 2010;51(13):629.
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To report the 3 month comparative outcomes for needle revision with bevacizumab and mitomycin C (MMC) verses MMC alone of failed trabeculectomy and Ex-PRESS shunt blebs.
Consecutive patients undergoing bleb needle revision procedures were enrolled in this study. All patients received a subconjunctival injection of 0.1 ml MMC (0.4mg/ml) mixed with 0.1 ml preservative free lidocaine (1%) at the beginning of the procedure. The patients were randomized into two cohorts assigned to receive either 1.0 mg (0.04 ml of 25 mg/ml) subconjunctival bevacizumab (Group 1) or 0.04 ml of balanced salt solution (Group 2) injected in an identical fashion posterior to the bleb following the bleb needling. Success is defined as 20% reduction in intraocular pressure (IOP) without any IOP lowering medications. Qualified success is defined as 20% reduction of IOP with IOP lowering medications. Failure is defined as IOP >21 mmHg, IOP reduction <20% despite medications, or need for additional surgery.
There was no significant difference between the pre-operative IOP between Group 1 (n=7) and Group 2 (n=9) (21.6 +/- 3.98 and 21.3 +/- 6.35, respectively; p=0.912). 3 months post-operatively, 100% of patients in Group 1 achieved complete success, while 22.2% of patients in Group 2 achieved complete success. Additionally, 33.3% of patients achieved qualified success in Group 2. The mean IOP at 3 months was 10.8 +/- 3.23 in Group 1 and 15.9 +/- 3.21 in Group 2 (p=0.007).
Bevacizumab may be a useful adjunct to improve the effectiveness of needle revision procedures of failed blebs after trabeculectomy or Ex-PRESS shunt surgery. Analysis of longer follow-up data is in process to further evaluate the use of bevacizumab in bleb needle revisions.
Clinical Trial: :
www.clinicaltrials.gov ID: NCT00853073; Study # 08-867
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