Study of the Safety and Efficacy of Anercortave Acetate for Treatment of Steroid Induced IOP Elevatio

Phase 2

Conditions: ocular hypertension
increased pressure inside the eye
10015917

Registration Number: NL-OMON30214

Lead Sponsor: ALCON/LABORATORIES

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

patients of either sex and any race/ethnicity, 18 years of age or older.
Patient that have received intravitreal steroid therapy.
Patients between 2 and 8 week (14 to 56 days) post-intravitreal steroid therapy with an IOP of at least 24 mmHg and who have 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.
Patient with at least 30 days of stable dosing of ocular hupotensive 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.

Exclusion Criteria

Patients on intravenous or subcutaneous anticoagulant therapy, or patient on oral anticoagulant therapy and cannot take a 5-day interruption in therapy prior to each injection procedure (with 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 screening.
Patients who are currently on therapy or were on therapy with systemic glucocorticoid medications within 30 days prior to Screening Visit.
Patients who have a known medical history of allergy to the steroid family of drugs.
History of ocular trauma wihin 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 administration.
History or other evidence of severe illness or any other condition which would make the patient, in the opinion of the Investigator, unsuitable for the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy endpoint will be the mean change in IOP (mmHg) from<br /><br>baseline to Week 4. Comparisons between the different treatment groups (3 mg,<br /><br>15 mg and 3O mg) and placebo will be made.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters will include the time to treatment failure and the<br /><br>pencentage of patients declared to be treatment failures.<br /><br>A target IOP will be established by the investigator. Patients for whom the<br /><br>IOP in the study eye exceeds the target IOP at Week 4, will come for an<br /><br>additional IOP measurement one week later. In case the target IOP is still<br /><br>exceeded, the patient is considered a treatment failure.</p><br>