Elevated intraocular pressure (IOP) following intravitreal injection with a corticosteroid (steroid induced IOP elavation).
Conditions
Interventions
Product Name: Anecortave Acetate (6 mg/ml)
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Anecortave
CAS Number: 7753-60-8
Current Sponsor code: AL-3789
Other descriptive name: An
Sponsors
Alcon Research Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients of either sex and any race/ethnicity, 18 years of age or older. Patients that have received intravitreal steroid therapy. Patients between 2 and 8 weeks (14 to 56 days) post-intravitreal steroid therapy with an IOP of at least 24 mmHg and who have had an IOP increase = 10 mmHg relative to their pre-steroid therapy in a single eye. NOTE: Only one eye per patient may be enrolled in the study. Only patients who satisfy all informed consent requirements may be included in the study. Patients with at least 30 days of stable dosing of ocular hypotensive medications prior to screening may be included. Patients using nonprescription and/or prescription topical ophthalmic and/or systemic non-glaucoma medications may be included in the study. Patients who wear contact lenses will be allowed to participate in the study provided that they are willing to discontinue use during the course of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient is on intravenous or subcutaneous anticoagulant therapy, or patient is on oral anticoagulant therapy (with the exception of aspirin and antiplatelet therapy) and cannot take a 5-day interruption in therapy prior to each injection procedure (with the exception of aspirin and antiplatelet therapy). Patients who are currently on therapy or were on therapy with another investigational agent within 30 days prior to the Screening Visit. Patients who are currently on therapy or were on therapy with systemic glucocorticoid medications within 30 days prior to the Screening Visit. Patients who have a known medical history of allergy to the steroid family of drugs. History of ocular trauma within the past six months in the study eye (eye to be treated). Patient with a history of penetrating glaucoma surgery (i.e. trabeculectomy, valves, etc.) in the study eye. Patient has had an insertion of scleral buckle in the study eye. Patients with a cup/disc ratio greater than 0.80 (horizontal or vertical measurement) in either eye. Any abnormality preventing reliable applanation tonometry of the study eye. Patients with clinical evidence of scleral thinning seen at the time of external eye examination or at the time of the administration. History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the safety and efficacy of Anecortave Acetate Depot (3, 15,or 30 mg) when administered by AJD for treatment of elevated IOP following intravitreal steroid therapy.;Secondary Objective: Secondary parameters will include the time to treatment failure and the percentage of patients declared treatment failures.;Primary end point(s): The primary efficacy endpoint will be mean change in IOP (mmHg) from baseline to Week 4. Hypothesis tests will be performed using repeated measures analysis of variance. Primary inference for this study will be based on the comparisons of mean change from baseline in IOP at the Week 4 visit between each of the Anecortave Acetate active drug groups (3 mg, 15 mg, 30 mg) versus Anecortave Acetate vehicle. Multiplicity will be adjusted using Hommel’s method. | — |
Countries
Belgium, Hungary, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed