EUCTR2006-003356-38-IT进行中（未招募）不适用
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 elevation
Alcon Research Limited0 个研究点目标入组 60 人开始时间: 2008年4月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
相似试验
进行中（未招募）
不适用
A Study of the Safety and Efficacy of Anecortave Acetate for Treatment of SteroidInduced IOP Elevation - Anecortave Acetate for Treatment of Steroid Induced IOP ElevatioElevated intraocular pressure (IOP) following intravitreal injection with a corticosteroid (steroid induced IOP elavation).EUCTR2006-003356-38-BEAlcon Research Limited60
进行中（未招募）
不适用
A Study of the Safety and Efficacy of Anecortave Acetate for Treatment of SteroidInduced IOP Elevation - Anecortave Acetate for Treatment of Steroid Induced IOP ElevatioElevated intraocular pressure (IOP) following treatment with a corticosteroid (steroid induced IOP elavation).EUCTR2006-003356-38-HUAlcon Research Limited60
进行中（未招募）
不适用
A Study of the Safety and Efficacy of Anecortave Acetate for Treatment of SteroidInduced IOP Elevation - Anecortave Acetate for Treatment of Steroid Induced IOP ElevatioEUCTR2006-003356-38-NLAlcon Research Limited60
进行中（未招募）
不适用
A Study of the Safety and Efficacy of Anecortave Acetate for Treatment of SteroidInduced IOP Elevation - Anecortave Acetate for Treatment of Steroid Induced IOP ElevatioEUCTR2006-003356-38-GBAlcon Research Limited60
尚未招募
2 期
Study of the Safety and Efficacy of Anercortave Acetate for Treatment of Steroid Induced IOP Elevatioincreased pressure inside the eye10015917ocular hypertensionNL-OMON30214ALCON/LABORATORIES6