Ozurdex for Retinal Vein Occlusion Study (ORVO Study)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex
研究概览
简要总结
To measure the pro-permeability factors in the aqueous humor of patients with persistent/recurrent macular edema after an injection of Ozurdex.
详细描述
To measure various pro-permeability factors in the aqueous humor of patients with persistent/recurrent macular edema despite prior treatment with anti-VEGF agents at baseline and at 4 weeks after intraocular injection of OZURDEX.
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
- •Signed informed consent and authorization of use and disclosure of protected health information
- •Age more than or equal to 18 years
- •Diagnosis of macular edema due to central or branch retinal vein occlusion
- •Intraretinal or subretinal fluid in the macula determined by Spectralis OCT
- •Best corrected visual acuity score in the study eye of 20/30 to 20/400 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters)
- •In the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from vein occlusion and not from other obvious causes of decreased vision
- •Persistent or recurrent edema despite prolonged treatment with an anti-VEFG agent
排除标准
- •Scatter laser photocoagulation or macular photocoagulation within 3 months of study entry in the study eye
- •Intraocular surgery in the study eye within 3 months of study entry
- •Use of intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) within 4 months of study entry
- •Previous use of an anti-VEGF drug within 1 month of study entry
- •Yttrium-Aluminum-Garnet (YAG) laser capsulotomy within 1 month of study entry
- •Any condition that the investigator believes would pose a significant hazard to the subject if investigational therapy were initiated.
- •Inability to comply with study or follow up procedures
- •History of glaucoma or documented history of steroid-induced glaucoma.
- •Patients with active or suspected ocular or periocular infection, including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
- •Aphakic eyes with rupture of the posterior lens capsule.
- •Eyes with ACIOL and rupture of the posterior lens capsule.
- •Patients with hypersensitivity to dexamethasone or to any other components of the product
研究组 & 干预措施
BRVO
Branch Retinal Vein Occlusion
干预措施: dexamethasone implant (Drug)
CRVO
Central Retinal Vein Occlusion
干预措施: dexamethasone implant (Drug)
结局指标
主要结局
Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex
时间窗: 4 months
Vasoactive protein arrays and Enzyme linked immunosorbent assays were done for patients at baseline and week 4 visit to measure the levels of various pro-permeability factors including VEGF, SDF-1 and Angiopoietin-2.
次要结局
未报告次要终点
研究者
Peter A Campochiaro, MD
MD
Johns Hopkins University