title: Treatment of steroid-induced elevated intraocular pressure with anecortave acetate: a randomized clinical trial.
abstract: OBJECTIVE
  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 30 mg) 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 24 mmHg and an IOP increase of at least 10 mmHg 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, 3 mg AA, 15 mg AA, or 30 mg AA. All patients then received a 0.5 mL 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 3.4 mmHg (9.1%) decrease from baseline. Reductions for the 3 mg AA (3.1 mmHg, 10.7%) and the 30 mg AA groups (5.4 mmHg, 16.6%) were not significantly different than for vehicle control. However, IOP for the 15 mg AA group at week 4 was reduced 11.5 mmHg (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, 3 mg AA, 15 mg AA, and 30 mg 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.
authors.affiliation: Department of Ophthalmology, Leuven University Hospitals, Leuven, Belgium.
authors.forename: Ingeborg
authors.initials: I
authors.lastname: Stalmans
authors.forename: David G
authors.initials: DG
authors.lastname: Callanan
authors.forename: Monte S
authors.initials: MS
authors.lastname: Dirks
authors.forename: Marlene R
authors.initials: MR
authors.lastname: Moster
authors.forename: Alan L
authors.initials: AL
authors.lastname: Robin
authors.forename: Joachim
authors.initials: J
authors.lastname: Van Calster
authors.forename: Sally A
authors.initials: SA
authors.lastname: Scheib
authors.forename: Jaime E
authors.initials: JE
authors.lastname: Dickerson
authors.forename: Theresa A
authors.initials: TA
authors.lastname: Landry
authors.forename: Michael V W
authors.initials: MV
authors.lastname: Bergamini
mesh_terms: D000328:Adult; D000368:Aged; D000869:Anterior Eye Segment; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D016503:Drug Delivery Systems; D005938:Glucocorticoids / Q000009:adverse effects*; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D011244:Pregnadienediols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012590:Sclera; D013997:Time Factors; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D005938:Glucocorticoids; D011244:Pregnadienediols; C418047:anecortave acetate