A Single Arm, Single Dose Study to Evaluate the Effect of Intravitreal Dexamethasone Implant (Ozurdex®) on Hard Exudates of Diabetic Macular Edema
试验速览
- 阶段
- 4 期
- 入组人数
- 48
- 试验地点
- 8
- 主要终点
- The ratio of eyes showing reduced hard exudates in macula (1500 micrometer from foveal center)
研究概览
简要总结
A Single Arm, Single Dose Study to Evaluate the Effect of intravitreal dexamethasone implant (Ozurdex®) on hard exudates of diabetic macular edema.
详细描述
Diabetic macular edema (DME) is important vision threatening complication of diabetes mellitus. Laser photocoagulation, vitrectomy, intravitreal steroid injection and intravitreal antiVEGF (anti vascular endothelial growth factor) injection are being used as treatment of DME. Sustained releasing intravitreal dexamethasone implant has been known to be effective in reducing the central retinal thickness and gain of vision for DME. Although hard exudate at macula is important pathology of DME, impact of intravitreal dexamethasone implant on hard exudate are not studied yet. Therefore the investigators designed the descriptive study to reveal the hard exudate change in DME eyes treated with intravitreal dexamethasone implant.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with CSME (clinically significant macular edema) with hard exudates within 1500 micrometer from foveal center
- •Those who have a BCVA (best corrected visual acuity) of study eye between 0.06(20/320) and 0.5(20/40)
- •Those who have a central macular thickness on OCT over 300 micrometer
- •If both eyes are eligible, eye having more hard exudates is selected (contralateral eye should be treated with corticosteroid other than Ozurdex or focal laser photocoagulation, anti-VEGF (vascular endothelial growth factor) injection is not allowed in contralateral eye)
排除标准
- •Those who have CSME without hard exudates
- •Those who have macular edema not related with diabetic retinopathy (e.g. AMD (age-related macular degeneration), uveitis, retinal vein occlusion and untreated malignant hypertension)
- •Those who have a history of Intraocular surgery (e.g. cataract surgery) within 3 months
- •Those who have a visual acuity of contralateral eye less than 0.1 (10/100)
- •Those who received focal laser treatment on macula within 3 months
- •Those who had intravitreal anti-VEGF agent injection within 3 months
- •Those who had intravitreal triamcinolone injection within 6 months
- •Those who have other ophthalmologic disease affecting visual acuity (e.g. central corneal opacity, cataract change at lens center)
- •Those who have severe systemic disease (e.g. uncontrolled DM, hypertension, cardiovascular disease, cerebrovascular disease)
- •Those who refuse to submit written consent
- •Those who cannot understand the contents of the clinical study and cooperate in the clinical trial
- •Those who are pregnant or lactating women
- •Those who have a history of vitrectomy
- •Those who require systemic corticosteroid or immunosuppressive agent treatment
- •Those who are banned from using Ozurdex
- •Ocular infection or periocular infection
- •Advanced glaucoma
- •Hypersensitivity to dexamethasone or other component of Ozurdex
- •Posterior lens capsule rupture or Aphakia
- •Anterior chamber intraocular lens or posterior capsule rupture
研究组 & 干预措施
Intravitreal dexamethasone implant
Intravitreal dexamethasone 0.7mg implant (Ozurdex)
干预措施: Intravitreal dexamethasone 0.7mg implant (Drug)
结局指标
主要结局
The ratio of eyes showing reduced hard exudates in macula (1500 micrometer from foveal center)
时间窗: after 12 months
次要结局
- The average change in ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity(after 12 months)
- The average change in number of microaneurysm in macula(after 12 months)
- The progression rate of cataract(for 12 months)
- The Ratio of eyes with central macular thickness under 290 micrometer in OCT (optical coherence tomography)(after 12 months)
- The Ratio of eyes showing reduced perifoveal capillary leakage in fluorescein angiography(after 12 months)
- Number of eyes having increased intraocular pressure(for 12 months)
研究者
Hyun Woong Kim
Associate professor
Inje University