Topical Nepafenac as Supplement for Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Topical Gutt Nepafenac 0.1%; Laser
Intervention type(s): Drug; Procedure
Intervention description(s): Topical Nepafenac as an adjunct to focal/grid laser; Grid/Focal Laser Photocoagulation
Other intervention name(s): Nevanac
Intervention MeSH terms: Nepafenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Diabetic Macular Edema; Nepafenac; Laser therapy; Clinically significant macular edema; Adjunct Treatment; Topical Nepafenac