Abstract
Purpose: :
To study the safety of adjunctive intravitreal ranibizumab for Ahmed valve surgery
Methods: :
A prospective Phase II single-center investigator-sponsored study. At the University of California San Francisco, 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 post-operative period. Outcomes assessed included: intraocular pressure (IOP), and potential complications including hypotony, hyphema, and flat anterior chamber.
Results: :
This is an ongoing study and thus far, 5 patients are in the ranibizumab group, and 4 patients are in the control group. The mean follow-up period is 5 months post-op. For the control group, the mean IOP was 18.5 ± 4.4 mmHg pre-operatively, and 16.0 ± 3.7 mmHg at last follow-up; the number of glaucoma medications reduced from 3 ± 1.4 pre-operatively to 1.5 ± 1.7 at last follow-up. For the ranibizumab group, the mean IOP was 20.6 ± 7.4 mmHg pre-operatively, and 16.2 ± 4.7 mmHg at last follow-up; the number of glaucoma medications reduced from 3.4 ± 2.3 pre-operatively to 0.6 ± 0.9 at last follow-up. The average reduction in the IOP was 4.4 ± 3.5 mmHg in the ranibizumab group and 2.5 ± 1.7 mmHg in the control group (p = 0.33). No significant complications have occurred in either group.
Conclusions: :
Preliminary results from this prospective, randomized, controlled trial suggest that intravitreal ranizibumab 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 • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • intraocular pressure