NCT00211406终止1 期
Treatment of Diabetic Retinopathy With Open-Label Anecortave Acetate Sterile Suspension (15 mg)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to provide compassionate use of anecortave acetate sterile suspension of 15 mg for a series of five patients as a means to control diabetic retinopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of patients with diabetic retinopathy.
- •Patients must be at least 18 years of age.
- •Visual acuity of 20/30 to 20/320 in study eye on the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity chart
- •Visual acuity of 20/800 or better in fellow eye on the ETDRS visual acuity chart
排除标准
- •Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
- •Patients who have undergone intraocular surgery within the last 2 months.
- •Patient participating in any other investigational drug study.
- •Use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication.
- •Inability to obtain photographs to document choroidal neovascularization (CNV) (including difficulty with venous access).
- •Patient with significant liver disease or uremia.
- •Patient with known adverse reaction to fluorescein and indocyanine green or iodine.
- •Patient has a history of any medical condition which would preclude scheduled visits or completion of study
- •Patient has had insertion of scleral buckle in the study eye
- •Patient has received radiation treatment
- •Patient is on anticoagulant therapy with the exception of aspirin
- •Patient is pregnant or nursing.
研究者
研究点 (1)
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