Prevention of Steroid-induced Glaucoma Using Anecortave Acetate
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Percentage of patients requiring glaucoma filtering surgery
研究概览
简要总结
Retisert implant is an effective therapy for controlling inflammation in patients with non-infectious posterior uveitis. One of the major complications of this device is the development of elevated intraocular pressure (IOP) following implantation in 60% of patients. Glaucoma filtering is required in over 30% of patients at 2 years. Anecortave acetate (AA) has been shown to reduce steroid induced elevated IOP. The purpose of this study was to evaluate the ability of prophylactic anterior juxtascleral depot administration of AA to prevent this Retisert induced elevated IOP.
详细描述
Test Article: Anecortave Acetate: 6% and 10% Sterile Suspension
Drug Study Dosage: Patients will receive an injection (0.5 mL, 0.4 mL, or 0.2 mL of the 6% Anecortave Acetate suspension or 0.5 mL of the 10% suspension) of study medication every 4 months.
Active Ingredients: Anecortave Acetate (AL-3789)
Route of Administration: Sub-Tenon injection
Objective(s): To evaluate the safety and efficacy of four dosages (50 mg, 30 mg, 24 mg, or 12 mg) of Anecortave Acetate (AA) for the prevention of steroid-induced intraocular pressure (IOP) elevations caused by Retisert.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Approximately 24 patients with recent implantation of the Retisert implant who meet the inclusion/exclusion criteria defined below will be enrolled in the study. They will be identified from the current and future patients of the clinical practices.
- •Patients must be willing to sign an informed consent form, able to make the required study visits, and able to follow instructions.
- •Patient must be at least 12 years of age.
- •Implantation of a Retisert implant in the last 12 weeks.
排除标准
- •Patient has history of any medical condition which would preclude scheduled study visits or completion of the study (i.e., unstable cardiovascular disease)
- •Patient has insertion of a scleral buckle in the study eye.
- •Patient has known medical history of allergy or sensitivity to the steroid family of drugs.
- •Patient is on anticoagulant therapy, with the exception of aspirin and antiplatelet therapy. Patient has a medical history of a bleeding disorder.
- •Patient has clinical evidence of scleral thinning.
研究组 & 干预措施
1
50 mgs of anecortave acetate (0.5 ml of a 10% suspension)
干预措施: anecortave acetate (Drug)
2
Patients will receive 30 mgs of anecortave acetate (0.5 ml of a 6% suspension)
干预措施: anecortave acetate (Drug)
3
Patients will receive 24 mgs of anecortave acetate (0.4 ml of a 6% suspension)
干预措施: anecortave acetate (Drug)
4
Patients will receive 12 mgs of anecortave acetate (0.2 ml of a 6% suspension)
干预措施: anecortave acetate (Drug)
结局指标
主要结局
Percentage of patients requiring glaucoma filtering surgery
时间窗: 3 years
次要结局
- Percentage of patients requiring topical glaucoma medication(3 years)