NCT01946399终止不适用
Dexamethasone Intravitreal Implant for Retinal Vein Occlusion Associated Macular Edema After Treatment Failure With Anti-VEGF Medications
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Improvement in best-corrected Snellen visual acuity following initiation of Ozurdex therapy
研究概览
简要总结
To determine if Ozurdex implant can offer an effective treatment for macular edema associated with retinal vein occlusion when treatment with intravitreal Avastin, Lucentis, or Eylea have not demonstrated a significant response.
详细描述
To determine whether Ozurdex implant can offer an efficacious alternative for treatment of macular edema in the setting of retinal vein occlusion when treatment with intravitreal bevacizumab (Avastin),ranibizumab (Lucentis), and/or aflibercept (Eylea) have not demonstrated significant response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 是
入选标准
- •All patients with Retinal Vein Occlusion (RVO) with available initial imaging and documented treatment failure with bevacizumab, ranibizumab, or aflibercept. Treatment failure is defined as lack of anatomic improvement (persistent intraretinal cystic changes/macular edema with central subfield thickness greater than 250 microns on time-domain OCT or greater than 275 microns on spectral domain OCT) with lack of visual improvement (less than 2 lines of visual gain by Snellen acuity), despite 3 to 6 intravitreal anti-VEGF treatments over the preceding 6 months.
排除标准
- •Co-existing or pre-existing macular degeneration, diabetic macular edema, or other confounding disease processes
- •Interval surgical intervention, such as cataract surgery, that may confound visual outcomes.
- •Pregnancy
- •Coexisting conditions that would represent relative or absolute contraindications usage of ozurdex implant, including:
- •Ocular or periocular infections (including viral disease of the cornea and conjunctiva such as active epithelial herpes simplex keratitis, vaccinia, varicella, mycobacterial infection, and fungal diseases)
- •Advanced glaucoma
- •Aphakic eyes with rupture or missing posterior lens capsule
- •Eyes with anterior chamber intraocular lens and missing posterior lens capsule
- •Patients with known hypersensitivity to components of this product
研究组 & 干预措施
Ozurdex implant
Other
Intravitreal injection of Ozurdex implant
干预措施: Ozurdex implant (Drug)
结局指标
主要结局
Improvement in best-corrected Snellen visual acuity following initiation of Ozurdex therapy
时间窗: 6 Months
次要结局
- Anatomic/angiographic improvement in macular edema as evaluated by OCT and fluorescein angiography(6 Months)
研究者
Rhonda Weeks
Gaurav K. Shah, MD
Retina Research Institute, LLC
研究点 (1)
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