E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Elevated intraocular pressure (IOP) following treatment with a corticosteroid (steroid induced IOP elavation). |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 steroid therapy. |
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E.2.2 | Secondary objectives of the trial |
Secondary parameters will include the time to treatment failure and the percentage of patients declared treatment failures. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients of either sex and any race/ethnicity, 18 years of age or older. 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. Patients 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. |
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E.4 | Principal 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 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. |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 7 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last patient visit, 6 months after entering the study. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |