Abstract
Purpose: :
To study the safety and efficacy of adjunctive intravitreal ranibizumab for Ahmed valve surgery.
Methods: :
A prospective Phase II single center investigator sponsored study. Glaucoma patients scheduled for Ahmed glaucoma valve surgery were randomized to observation or intravitreal ranibizumab. The treatment group received ranibizumab (0.5 mg) 7 days prior to surgery and injection monthly times 2 in the postoperative period. Outcomes assessed include: intraocular pressure (IOP) and potential complications including hypotony, hyphema, and flat anterior chamber.
Results: :
This in an ongoing study and thus far, four patients have been enrolled in this study. Two participants are in the observation group and 2 participants are in the ranibizumab group. The mean follow up period is 2 months post-op. The mean IOP in the control group was 17±0.71 mmHg, pre-operative, and was 16±3.5 mmHg at last follow-up. The number of glaucoma medications was reduced from an average of 1.5±0.71, pre-operative, to 0, at last follow-up. In the ranibizumab group, the mean pre-operative IOP was 16±3.5 mmHg, and the mean follow-up IOP was 10±0.0 mmHg. Mean number of glaucoma medications was reduced from 1.5±0.71, pre-operative, to 0, at last follow-up. The average reduction in the IOP was 5.5 mmHg compared to 0.5 mmHg for the observation group (P=0.29). No significant complications have occurred in either group.
Conclusions: :
Preliminary results from this prospective, randomized, controlled trial suggest that intravitreal ranibizumab may help maintain IOP control after Ahmed valve surgery. This is an ongoing study and further results will be presented.
Clinical Trial: :
www.clinicaltrials.gov NCT00644280
Keywords: wound healing • intraocular pressure