Topical Dexamethasone - Cyclodextrin Microparticle Eye Drops for Diabetic Macular Edema
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Best Corrected Visual Acuity on ETDRS chart
研究概览
简要总结
The research group has developed new ocular drug delivery technology based on cyclodextrin nanoparticles (NP). The investigators plan to develop and test this technology to help treat diabetic macular edema (DME).
An important step in research was the invention of cyclodextrin nanoparticles, which has just received a US patent. The investigators pre-clinical and clinical work has demonstrated the investigators eye drop suspension with cyclodextrin nano-particles to be superior to conventional eye drops. They increase drug absorbance into the eye and decrease systematic distribution of the drug, hence reducing side effects. Cyclodextrin nanoparticle eye drops deliver drugs to the posterior part of the eye, thus solving one of the biggest obstacles in ocular pharmacology.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus
- •Pseudophakic in study eye, i.e. with IOL (intra ocular lens) after cataract surgery
- •Diabetic macular edema with central macular thickness over 300 µm on OCT in study eye. If both eyes have DME, then the treatment will be applied to the eye with thicker central macula on OCT.
- •Age 18 years or older
排除标准
- •Glaucoma or use of any glaucoma medication
- •Known steroid IOP response
- •Any infectious eye disease
- •Treatment for DME within 6 months, such as laser treatment, intravitreal or subtenon injections of steroids, intravitreal injections of anti vascular endothelelial growth factor medication.
- •Any eye surgery within 3 months or other eye conditions e.g. corneal disorders, ocular hypotony and retinal detachments.
- •Crystalline lens present in study eye
- •Known allergy to cyclodextrins, dexamethasone, ranibizumab or any of the components of the study medications
研究组 & 干预措施
dexamethasone - Cyclodextrin
干预措施: dexamethasone - Cyclodextrin eye drops (Drug)
Avastin/Laser
干预措施: intravitreal Avastin injection +/- macular laser (Other)
结局指标
主要结局
Best Corrected Visual Acuity on ETDRS chart
时间窗: 3 months
次要结局
- Intraocular pressure (IOP)(3 months)
研究者
Ahmed Abu El-Asrar
Professor, Consultant, Vitreoretinal/Uveitis division
King Saud University