Effect of Intravitreal Long Acting Dexamethasone Implant, Ozurdex in Patients With Diabetic Macular Edema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- change in central macular thickness
研究概览
简要总结
This study is undertaken to determine the effect of intravitreal long acting dexamethasone implant,(Ozurdex®)in patients with diabetic macular edema.Diabetic macular edema is important cause of visual impairment in patients with diabetes mellitus. Focal/ grid laser photocoagulation is the standard of care in its management. Several adjuncts including intravitreal corticosteroids, Pegabtanib Sodium ,Ranibizumab, Bevacizumab, non-steroidal anti-inflammatory agents, corticosteroids, laser photocoagulation have been tried. Intravitreal Triamcinolone Acetonide (TA), a water insoluble steroid, has been shown to reduce the retinal thickness and improve the visual acuity. However, recurrence of macular edema in patients who receive intravitreal TA is a major concern as the patients need multiple repeat injections because of its short half life. A more potent steroid, dexamethasone has also been tried as an alternative to TA for macular edema; however, its short half life of only 3 hours prevents its clinical application. In search for the ideal corticosteroid preparation, a Dexamethasone Posterior Segment Drug Delivery System (Dexamethasone DDS - Ozurdex®, Allergan Inc, Irvine, California) was recently developed. Promising results have been shown in certain patients with retinal vein occlusions, uveitis receiving this intravitreal drug delivery system with improvement in visual acuity. The present study introduces a novel concept of using Ozurdex ® implant in patients with diabetic macular edema.
详细描述
This study is undertaken to determine the effect of intravitreal long acting dexamethasone implant,(Ozurdex®)in patients with diabetic macular edema.Diabetic macular edema is important cause of visual impairment in patients with diabetes mellitus. Focal/ grid laser photocoagulation is the standard of care in its management. Several adjuncts including intravitreal corticosteroids, Pegabtanib Sodium ,Ranibizumab, Bevacizumab, non-steroidal anti-inflammatory agents, corticosteroids, laser photocoagulation have been tried. Intravitreal Triamcinolone Acetonide (TA), a water insoluble steroid, has been shown to reduce the retinal thickness and improve the visual acuity. However, recurrence of macular edema in patients who receive intravitreal TA is a major concern as the patients need multiple repeat injections because of its short half life. A more potent steroid, dexamethasone has also been tried as an alternative to TA for macular edema; however, its short half life of only 3 hours prevents its clinical application. In search for the ideal corticosteroid preparation, a Dexamethasone Posterior Segment Drug Delivery System (Dexamethasone DDS - Ozurdex®, Allergan Inc, Irvine, California) was recently developed. Promising results have been shown in certain patients with retinal vein occlusions, uveitis receiving this intravitreal drug delivery system with improvement in visual acuity. The present study introduces a novel concept of using Ozurdex ® implant in patients with diabetic macular edema.
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 72 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patients of Type 1 or Type 2 Diabetes Mellitus fulfilling the following inclusion criteria shall be enrolled in the study:
- •Patients of Non Proliferative Diabetic retinopathy (NPDR)with clinicaly significant macular edema(CSME)
- •Patients with Proliferative Diabetic Retinopathy (PDR) with CSME where proliferative component has been adequately treated with laser photocoagulation
- •Diabetic patients withcystoid macular edema
- •Minimum central thickness on OCT not less than 300 microns
排除标准
- •Patients with history of ocular hypertension or glaucoma
- •Patients with media haze or pupillary non-dilation that does not allow good fundus photography, FFA and OCT.
- •Patients with macular ischemia on FFA
研究组 & 干预措施
Ozurdex in diabetic macular edema
Intravitreal ozurdex given in patients with diabetic macular edema and patients followed up for change in central macular thickness and visual acuity over period of 6 months
干预措施: long acting intravitreal dexamethasone implant (Drug)
结局指标
主要结局
change in central macular thickness
时间窗: Baseline and 6 months
The primary outcome is the change in the central macular thickness, either an increase or decrease, as measured by optical coherence tomography as compared to baseline central macular thickness
次要结局
- Change in the visual acuity(Baseline and 6 months)
研究者
Pooja Bansal,MD
MD
Post Graduate Institute of Medical Education and Research, Chandigarh
