Purpose: The present study is the first randomized clinical trial designed to evaluate the intraocular pressure (IOP)-lowering effect of anecortave acetate (AA) administered at 3 doses (3, 15, or 30mg) as an anterior juxtascleral depot (AJD) in patients experiencing elevated IOP due to corticosteroid therapy. Methods: This was a double-masked, randomized, placebo-controlled, multicenter, parallel group trial. Eligible patients had an IOP of at least 24mmHg and an IOP increase of at least 10mmHg relative to their IOP before treatment with steroids. A target IOP was established for each patient at baseline. Patients were randomized to 1 of the 4 treatment groups: vehicle, 3mg AA, 15mg AA, or 30mg AA. All patients then received a 0.5mL AJD of the assigned treatment. Patients returned for scheduled examination visits at weeks 1, 2, 4, 6, months 3, 4, 5, and 6. IOP was measured at each visit as well as best corrected visual acuity (logMAR), ocular motility, eyelid responsiveness, slit lamp examination, and assessment of any adverse events. In addition, at baseline and at exit, a dilated fundus examination was carried out and the lens was examined using LOCS II criteria. Results: Seventy patients were randomized to treatment. At week 4, eyes in the vehicle group showed a 3.4mmHg (9.1%) decrease from baseline. Reductions for the 3mg AA (3.1mmHg, 10.7%) and the 30mg AA groups (5.4mmHg, 16.6%) were not significantly different than for vehicle control. However, IOP for the 15mg AA group at week 4 was reduced 11.5mmHg (31.3%) from baseline, which was statistically significant (P=0.0487). The mean time to treatment failure was 32.2, 38.9, 56.3, and 32.6 days for the vehicle, 3mg AA, 15mg AA, and 30mg AA groups, respectively. Adverse events were assessed at each post-treatment visit. There were no serious adverse events that were determined to be related to the test article or its administration. Conclusions: AA can be of benefit to some patients requiring treatment with corticosteroids, but suffering from the side effect of elevated IOP.
ASJC Scopus subject areas
- Pharmacology (medical)