Steroid vs. Anti-vascular Endothelial Growth Factor for Diabetic Macular Edema Prior to Phacoemulsification
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Comparison of central foveal thickness outcomes of anti-vascular endothelial growth factor vs. Ozurdex therapy
研究概览
简要总结
The primary objective of this study is to compare the efficacy of antecedent intravitreal anti-vascular endothelial growth factor therapy vs. Ozurdex in reducing post-cataract surgery related macular edema in patients with pre-existing diabetic macular edema.
详细描述
In patients with pre-existing diabetic macular edema, anti-vascular endothelial growth factor therapy (Bevacizumab, ranibizumab, or aflibercept) will be compared to Ozurdex therapy administered 1 week prior to phacoemulsification cataract extraction. Spectral domain optical coherence tomography and visual acuity will be acquired at 1 week, 1 month, 2 months, and 3 months following cataract surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age > 18 years of age
- •Gender- All
- •Race- All
- •Diagnosis of Diabetes (Type 1 or 2) with a concomitant diagnosis of diabetic macular edema as demonstrated on spectral domain optical coherence tomography (Heidelberg Spectralis)
- •>250 microns central foveal thickness
- •Able and willing to provide informed consent
排除标准
- •Significant renal disease
- •A condition that in the opinion of the investigator would preclude participation
- •Participation in another investigational trial within 30 days of randomization
- •Application of focal macular laser within 120 days of enrollment
- •Administration of Iluvien implant within 3 years of enrollment
- •Administration of intravitreal triamcinolone within 3 months of enrollment
- •Administration of any anti-vascular endothelial growth factor agent within 30 days of enrollment
- •Known hypersensitivity to any of the investigational products
- •Blood pressure >180/110
- •Women who are pregnant, lactating, or intend to become pregnant within 1 year of randomization
- •Vulnerable populations- including but not limited to wards of the state, cognitively impaired individuals, prisoners, institutionalized individuals
- •Individual is planning on moving within 6 months of study enrollment
- •Macular edema secondary to cause other than diabetic macular edema
- •Ocular condition that, in the opinion of the investigators, may affect course of macular edema during course of study (vein occlusion, uveitis, etc.)
- •Evidence of ocular infections
- •Evidence of uncontrolled glaucoma
- •Known hypersensitivity to any components of bevacizumab, ranibizumab, aflibercept, or Ozurdex
研究组 & 干预措施
Anti-vascular endothelial growth factor
Intravitreal Bevacizumab, Ranibizumab, or Aflibercept
干预措施: Bevacizumab (Drug)
Anti-vascular endothelial growth factor
Intravitreal Bevacizumab, Ranibizumab, or Aflibercept
干预措施: Ranibizumab (Drug)
Anti-vascular endothelial growth factor
Intravitreal Bevacizumab, Ranibizumab, or Aflibercept
干预措施: Aflibercept (Drug)
Ozurdex
Intravitreal Ozurdex
干预措施: Ozurdex (Drug)
结局指标
主要结局
Comparison of central foveal thickness outcomes of anti-vascular endothelial growth factor vs. Ozurdex therapy
时间窗: 3 months after cataract surgery
Central foveal thickness will be measured in microns by spectral domain optical coherence tomography (Heidelberg) and compared to baseline at post-operative week 1, postoperative month 1, postoperative month 2, and postoperative month 3 for both anti-vascular endothelial growth factor and Ozurdex groups
次要结局
- Visual acuity outcomes of anti-vascular endothelial growth factor vs. Ozurdex therapy(3 months after cataract surgery)
研究者
Caesar Luo, MD, FACS
Physician
Bay Area Retina Associates