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Treatment of steroid-induced elevated intraocular pressure with anecortave acetate: a randomized clinical trial.

ABSTRACT: 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.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.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.AA can be of benefit to some patients requiring treatment with corticosteroids, but suffering from the side effect of elevated IOP.

SUBMITTER: Stalmans I

PROVIDER: S-EPMC3505827 | biostudies-literature | 2012 Dec

REPOSITORIES: biostudies-literature

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Treatment of steroid-induced elevated intraocular pressure with anecortave acetate: a randomized clinical trial.

Stalmans Ingeborg I Callanan David G DG Dirks Monte S MS Moster Marlene R MR Robin Alan L AL Van Calster Joachim J Scheib Sally A SA Dickerson Jaime E JE Landry Theresa A TA Bergamini Michael V W MV

Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics 20120803 6

<h4>Purpose</h4>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.<h4>Methods</h4>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 a ...[more]

PMID: 22860637

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Project description:ObjectiveTo report the 2-year incidence of raised intraocular pressure (IOP) and glaucomatous optic nerve damage in patients with uveitis randomized to either fluocinolone acetonide (FA) implants or systemic therapy. Secondarily, we sought to explore patient and eye characteristics associated with IOP elevation or nerve damage.DesignA randomized, partially masked trial in which patients were randomized to either FA implants or systemic therapy.ParticipantsPatients aged ? 13 years with noninfectious intermediate, posterior, or panuveitis active within the prior 60 days for which systemic corticosteroids were indicated were eligible.MethodsVisual fields were obtained at baseline and every 12 months using the Humphrey 24-2 Swedish interactive threshold algorithm (SITA) fast protocol. Stereoscopic optic nerve photos were taken at baseline and at 3-, 6-, 12-, and 24-month follow-up visits. Masked examiners measured IOP at every study visit.Main outcome measuresGlaucoma was diagnosed based on an increase in optic nerve cup-to-disc ratio with visual field worsening or increased cup-to-disc ratio alone, for cases where visual field change was not evaluable, because of missing data or severe visual field loss at baseline.ResultsMost patients were treated as assigned; among those evaluated for glaucoma, 97% and 10% of patients assigned to implant and systemic treatment, respectively, received implants. More patients (65%) assigned to implants experienced an IOP elevation of ? 10 mmHg versus 24% assigned to systemic treatment (P<0.001). Similarly, 69% of patients assigned to the implant required IOP-lowering therapy versus 26% in the systemic group (P<0.001). Glaucomatous optic nerve damage developed in 23% versus 6% (P<0.001) of implant and systemic patients, respectively. In addition to treatment assignment, black race, use of IOP-lowering medications, and uveitis activity at baseline were associated with incident glaucoma (P<0.05).ConclusionsImplant-assigned eyes had about a 4-fold risk of developing IOP elevation of ? 10 mmHg and incident glaucomatous optic neuropathy over the first 2 years compared with those assigned to systemic therapy. Central visual acuity was unaffected. Aggressive IOP monitoring with early treatment (often including early filtration surgery) is needed to avoid glaucoma when vision-threatening inflammation requires implant therapy.Financial disclosure(s)Proprietary or commercial disclosure may be found after the references.

Project description:IntroductionWith the increasing use of intravitreal administration of corticosteroids in macular edema, steroid-induced intraocular pressure (IOP) rise is becoming an emergent issue. However, for patients in whom intravitreal steroids are indicated, there are no specific recommendations for IOP monitoring and management after intravitreal administration of corticosteroids.MethodAn expert panel of European ophthalmologists reviewed evidence on corticosteroid-induced IOP elevation. The objective of the panel was to propose an algorithm based on available literature and their own experience for the monitoring and management of corticosteroid-induced IOP elevation, with a focus on diabetic patients.ResultsData from trials including diabetic patients with a rise of IOP after intravitreal steroid administration indicate that IOP-lowering medical treatment is sufficient for a large majority of patients; only a small percentage underwent laser trabeculoplasty or filtering filtration surgery. A 2-step algorithm is proposed that is based on the basal value of IOP and evidence for glaucoma. The first step is a risk stratification before treatment. Patients normotensive at baseline (IOP ≤ 21 mmHg), do not require additional baseline diagnostic tests. However, patients with baseline ocular hypertension (OHT) (IOP > 21 mmHg) should undergo baseline imaging and visual field testing. The second step describes monitoring and treatment after steroid administration. During follow-up, patients developing OHT should have baseline and periodical imaging and visual field testing; IOP-lowering treatment is proposed only if IOP is >25 mmHg or if diagnostic tests suggest developing glaucoma.ConclusionThe management and follow-up of OHT following intravitreal corticosteroid injection is similar to that of primary OHT. If OHT develops, IOP is controlled in a large proportion of patients with standard IOP treatments. The present algorithm was developed to assist ophthalmologists with guiding principles in the management of corticosteroid-induced IOP elevation.FundingAlimera Sciences Limited.

Project description:BACKGROUND:To compare the effect of selective laser trabeculoplasty (SLT) and travoprost on 24-hour IOP fluctuations in primary open-angle glaucoma (POAG) and normal-tension glaucoma (NTG). METHODS:Sixty eyes were included. Sixteen and 14 eyes of POAG patients were randomized to receive 360° SLT or 0.004% travoprost, respectively. Fourteen and 16 eyes of NTG patients were randomized to receive either SLT or travoprost, respectively. The 24-hour IOP data were collected before treatment and 6 to 8 weeks after treatment. IOP was measured at 2?hours intervals in the sitting position during daytime (9 AM to 7 PM) and in the supine position during nighttime (9 PM to 7 AM). Main outcome measure was the percentage of eyes that achieved posttreatment 24-hour IOP fluctuations <3?mm?Hg. Success in fluctuation reduction was defined as at least a 50% reduction in these fluctuations. RESULTS:Fifty-eight eyes were analyzed. Overall, eyes in the SLT and the travoprost groups achieved a significant reduction in IOP compared with the baseline IOP values (-3.7?mm Hg [P?=?0.002] vs -4.1?mm Hg [P?<?0.001], respectively). There was no significant difference in IOP reduction in both groups according to type of glaucoma. During the diurnal period, 100% of POAG eyes in the travoprost group achieved posttreatment IOP fluctuations <3?mm Hg, and 87% of eyes in the SLT group achieved the same level of fluctuations (P?<?0.001). Ninety-six percent of NTG eyes in the travoprost group, and 82% of eyes in the SLT group had IOP fluctuations <3?mm Hg (P?=?0.01). Success in fluctuation reduction was 75% and 92% for the SLT and travoprost groups, respectively (P?=?0.005). The effect of travoprost on IOP reduction in POAG and NTG patients was significant both during the daytime and the nighttime, while the SLT's effect was significant only during the nighttime. CONCLUSIONS:Both travoprost and SLT can significantly reduce the IOP in patients with POAG and NTG. Based on habitual positions, travoprost better controls IOP fluctuations than SLT, especially during the daytime.

Dataset Information

Treatment of steroid-induced elevated intraocular pressure with anecortave acetate: a randomized clinical trial.

Publications

Treatment of steroid-induced elevated intraocular pressure with anecortave acetate: a randomized clinical trial.

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