Estudio de la seguridad y eficacia de acetato de anecortave para el tratamiento de la elevación de la PIO inducida por esteroides.A Study of the Safety and Efficacy of Anecortave Acetate for Treatment of SteroidInduced IOP Elevation - Anecortave Acetate for Treatment of Steroid Induced IOP Elevation

Alcon Research Limited0 个研究点目标入组 60 人开始时间: 2007年12月3日最近更新: 2018年12月10日

适应症

试验速览

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•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
•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

•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.

发起方

Alcon Research Limited