A study of the Safety and Efficacy of Anecortave Acetate for Treatment of Steroid Induced IOP Elevation - Anecortave Acetate for treatment of steroid induced IOP elevatio
- Conditions
- patient with elevated intraocular pressure following steroid treatment (any route).MedDRA version: 9.1Level: LLTClassification code 10030043Term: Ocular hypertension
- Registration Number
- EUCTR2006-003356-38-IT
- Lead Sponsor
- Alcon Research Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
1. Patients of either sex and any race/ethnicity, 18 years of age or older. 2. Patients that have been treated with steroids by any route, intravitreal or periocular injection (but excluding fluocinolone acetonide ocular implants), topical ocular, other topical administration, inhaled, or chronic systemic. 3. Patients with an IOP of at least 24 mmHg and who have had an IOP increase of at least 10 mmHg relative to their pre-steroid therapy IOP in a single eye, and in the opinion of the Investigator there is a plausible cause/effect relationship between the steroid exposure and the subsequent elevated IOP; NOTE: only one eye per patient may be enrolled in the study. 4. Only patients who satisfy all informed consent requirements may be included in the study. 5. Patients with at least 30 days of stable dosing of ocular hypotensive medications prior to screening may be included. 6. Patients using nonprescription and/or prescription topical ophthalmic and/or systemic non-glaucoma medications may be included in the study. 7. 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
1. Females of childbearing potential (those who are not surgically sterilized or postmenopausal) are excluded from participation in the study if they meet any one of the following conditions: They are currently pregnant or, they have a positive result on the urine pregnancy test at the Screening Visit or, they intend to become pregnant during the study period or, they are breast-feeding or, they are not using highly effective birth control measures. 2. 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. 3. Patients who are currently on therapy or were on therapy with another investigational agent within 30 days prior to the Screening Visit. 4. Patients who have a known medical history of allergy to the steroid family of drugs. 5. History of ocular trauma within the past six months in the study eye (eye to be treated). 6. Patient with a history of penetrating glaucoma surgery (i.e. trabeculectomy, valves, etc.) in the study eye. 7. Patient has had an insertion of scleral buckle in the study eye. 8. Patients with a cup/disc ratio greater than 0.80 (horizontal or vertical measurement) in either eye. 9. Any abnormality preventing reliable applanation tonometry of the study eye. 10. Patients with clinical evidence of scleral thinning seen at the time of external eye examination or at the time of the administration.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to evaluate safety and efficacy of Anecortave Acetate depot (3 mg, 15 mg and 30 mg)when administred by anterior iuxta scleral injection for treatment of elevated IOP following 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 will be based on the comparison of mean change from baseline in IOP at Week 4 visit between each of the Anecortave Acetate active groups versus placebo (Anecortave vehicle). Multiplicity will be adjusted using Hommell's method.
- Secondary Outcome Measures
Name Time Method