Study of the Safety and Efficacy of Anercortave Acetate for Treatment of Steroid Induced IOP Elevation - Anecortave Acetate for Treatment of Steroid Induced IOP Elevation

ALCON/LABORATORIES0 个研究点目标入组 6 人开始时间: 待定最近更新: 2024年5月13日

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•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.

•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.

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ALCON/LABORATORIES