Diabetic Macular Edema Treated With Ozurdex (DMEO)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Correlation Between Change in Level of Propermeability Factors With Change in Edema After Treatment With a Dexamethasone Implant or Anti-VEGF Agent
研究概览
简要总结
To measure various pro-permeability factors in the aqueous humor of patients with persistent/recurrent diabetic macular edema
详细描述
Patients with Diabetic Macular Edema (DME) are increasingly being treated with molecules targeting vascular endothelial factor (VEGF). One potential advantage of a dexamethasone implant over specific VEGF antagonists is that steroids suppress production of multiple pro-permeability factors.
Our primary objective is to measure the 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 1, 2, 3, and 4 months after intraocular injection of a dexamethasone implant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（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 diabetic macular edema
- •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 DME 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. (Patients who have undergone filtration surgery may be included)
- •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
Group 1 (dexamethasone implant/anti-VEGF)
Patients in group 1 received an injection of an dexamethasone implant at baseline followed by PRN anti-VEGF injections after crossover at week 16.
干预措施: Dexamethasone Implant (Drug)
Group 2 (anti-VEGF/dexamethasone implant)
Patients in group 2 received prn anti-VEGF injections followed by injection of a dexamethasone implant after crossover at week 16.
干预措施: Anti-VEGF injection (Drug)
Group 1 (dexamethasone implant/anti-VEGF)
Patients in group 1 received an injection of an dexamethasone implant at baseline followed by PRN anti-VEGF injections after crossover at week 16.
干预措施: Anti-VEGF injection (Drug)
Group 2 (anti-VEGF/dexamethasone implant)
Patients in group 2 received prn anti-VEGF injections followed by injection of a dexamethasone implant after crossover at week 16.
干预措施: Dexamethasone Implant (Drug)
结局指标
主要结局
Correlation Between Change in Level of Propermeability Factors With Change in Edema After Treatment With a Dexamethasone Implant or Anti-VEGF Agent
时间窗: 1, 2, 3, and 4 months after injection of a dexamethasone implant or anti-VEGF agent
Changes in propermeability factor levels were correlated with changes in edema using the person correlation coefficient (this was calculated using data from all time points).
次要结局
未报告次要终点
研究者
Peter A Campochiaro, MD
Professor of Ophthalmology and Neuroscience
Johns Hopkins University