跳至主要内容
临床试验/NCT02443012
NCT02443012已完成4 期

Evaluation on Efficacy of Topical Nepafenac as Supplement Therapy in the Treatment of Diabetic Macular Edema

Universiti Sains Malaysia2 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2013年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
47
试验地点
2
主要终点
Changes in Logarithm Best Minimal Angle of Resolution Corrected Visual Acuity (LogMAR BCVA) (Measurement of Visual Acuity)

研究概览

简要总结

Diabetic macular edema (DME) is a major cause of visual loss in patients with diabetes mellitus. The standard treatment is with focal/grid laser therapy. Topical nepafenac was used as an adjunct therapy for treatment of DME.

The aim of this study is to compare the difference of best corrected visual acuity (BCVA) and central macular thickness (CMT) at 3 months post treatment between combination therapy of laser and topical nepafenac and laser monotherapy in patients with DME.

详细描述

Diabetes mellitus with its systemic complications has been an enormous health treat to the world population today. In the US, the ophthalmic related complications has been estimated to cause up to 4.2 million (28.5%) people in 2005 till 2008 to suffer from blindness. One of the most common causes of visual acuity loss in patients with diabetes mellitus is diabetic macular edema (DME).

The gold standard of treatment for clinically significant macular edema (CSME), a form of DME, is through focal and grid laser as shown by the Early Treatment Diabetic Retinopathy Study. The development of newer drugs such as anti vascular endothelial growth factors anti (VEGFs), an alternative to laser treatment, has become a topic of interest in the recent years. Other alternative to treatment of DME is steroid such as triamcinolone injection and dexamethasone injections. However, both anti VEGFs and steroids are expensive and not readily available in all centres. Both types of medications require repeated treatment and the route of administration through intravitreal also poses risk of endophthalmitis, lens injury, retinal detachment, vitreous hemorrhage, increase in intraocular pressure and cataract.

The pathophysiology of DME is not fully understood yet. It was suggested that it is likely to be a chronic low-grade inflammation. Through this theory, topical non-steroidal anti-inflammatory drugs (NSAIDs) have been used to treat DME. The investigators postulate that the addition of topical NSAIDs in patients receiving standard treatment of laser therapy may help to improve the outcome of patients with DME. It has the advantage of no needles involved, convenient, easy to use and minimal side effects. The aim of this study is to evaluate the outcome of visual acuity and macular thickness at 3 months post treatment between laser monotherapy and combination of laser and topical nepafenac in DME.

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 Diabetes Mellitus with CSME
  • Aged 18 to 70 years old
  • Clear media (Able to perform OCT)
  • HbA1c less than 12% at 3 months

排除标准

  • CSME with severe Non-Proliferative Diabetic Retinopathy (NPDR) or Proliferative Diabetic Retinopathy(PDR)
  • Previous laser treatment
  • Previous ocular injury or surgery
  • History of taking topical or systemic anti inflammatory agents
  • Allergic to NSAIDs
  • Other ocular pathology (ARMD, Glaucoma, IPCV)
  • High myope

研究组 & 干预措施

Laser

Placebo Comparator

Patients with CSME treated with argon laser photocoagulation (focal/grid laser)

干预措施: Laser (Procedure)

Nevanac

Experimental

Patients with CSME treated with argon laser photocoagulation (focal/grid laser) and Topical Gutt Nepafenac 0.1% given 8 hourly interval for 3 months

干预措施: Topical Gutt Nepafenac 0.1% (Drug)

Nevanac

Experimental

Patients with CSME treated with argon laser photocoagulation (focal/grid laser) and Topical Gutt Nepafenac 0.1% given 8 hourly interval for 3 months

干预措施: Laser (Procedure)

结局指标

主要结局

Changes in Logarithm Best Minimal Angle of Resolution Corrected Visual Acuity (LogMAR BCVA) (Measurement of Visual Acuity)

时间窗: 3 months

Measurement of Best Corrected Visual Acuity by means of refraction using the ETDRS Chart

次要结局

  • Changes in central macular thickness (measurement of macular thickness)(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jan Bond Chan

Dr

Universiti Sains Malaysia

研究点 (2)

Loading locations...

相似试验