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E. R. Craven, A. L. Robin, R. M. Feldman, S. A. Scheib, J. E. Dickerson, T. A. Landry, D. T. Wells, A. F. Clark, M. V. W. Bergamini; Control of IOP in Open-Angle Glaucoma by Anecortave Acetate: A Comparison of Three Doses and Vehicle. Invest. Ophthalmol. Vis. Sci. 2008;49(13):1207.
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To evaluate the safety and intraocular pressure (IOP)-lowering efficacy of anecortave acetate (AA) ophthalmic suspension (3, 15, and 30 mg) compared to vehicle, administered as a single anterior juxtascleral depot (AJD) in patients with a clinical diagnosis of open-angle glaucoma (OAG).
This was a randomized double-masked multi-center (N=10) study. Eligible patients had a clinical diagnosis of OAG and eligibility IOP between 24 and 36 mmHg in the study eye. Qualifying patients were randomized to receive a single 0.5 mL AJD of anecortave acetate (3, 15, or 30 mg) or vehicle in the "worse" eye. The fellow, non-injected eye was treated with latanoprost. On-therapy visits were at 2, 6 and 12 weeks. Success was defined as an IOP 21 mmHg.
85 of 86 patients were evaluable by ITT. 42% of the patients were on multiple IOP-lowering medications prior to the study. Mean baseline IOP was similar across all four treatment groups for both eyes (range=27.1 to 28.3 mmHg, injected eye; 22.8 to 25.5 mmHg, fellow eye). At 3 months, the success rate (IOP 21 mmHg) was similar for the 3 and 15 mg groups (approximately 30%) and was 50% for the 30 mg group. This was about two-fold that seen for the vehicle group (24%). Patients considered treatment successes had similar mean IOP reductions in the study eye (regardless of dose) of -8, -6.7, and -7 mmHg for 3, 15, and 30 mg, respectively, compared to -1.4 mmHg for the vehicle treated group. Interestingly, mean IOP reductions for the latanoprost-treated fellow eyes ranged between -5 and -7 mmHg depending on the treatment group. The most common adverse events were eye pain, foreign body sensation, and blurred vision. Of the 14 reports of eye pain, 9 (64%) were related to the injection procedure.
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