NCT00211354撤回2 期
Treatment of Retinal Vein Occlusion (RVO) With Open-Label Anecortave Acetate (15mg.)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- to investigate the use of anecortave acetate for treatment of retinal vein occlusion
研究概览
简要总结
Retinal Vein Occlusion is a blockage of the blood vessels that drain out of the retina. Complications of retinal vein occlusion which threaten vision include neovascularization(growth of new blood vessels)and macular edema ( accumulation of fluid "leaking" from abnormal blood vessels). Currently, the treatment of retinal vein occlusion is laser photocoagulation. This treatment has found to have limited use in this type of condition.Anecortave Acetate is being considered as an attempt to control the growth of the abnormal blood vessels.
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 Retinal Vein Occlusion.
- •Patients must be 18 years of age or older to receive treatment.
- •Visual acuity of 20/30 to 20/320 Study Eye on the ETDRS visual acuity chart.
- •Visual acuity of 20/800 or better 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 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 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.
研究组 & 干预措施
anecortave acetate
Experimental
anecortave acetate 15 mg. juxtascleral injection every 6 months for 24 months
干预措施: Anecortave Acetate (Drug)
结局指标
主要结局
to investigate the use of anecortave acetate for treatment of retinal vein occlusion
时间窗: 24 months
次要结局
- mean change of VA (ETDRS) from baseline to 24 months(24 months)
研究者
研究点 (1)
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