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Completed

NCT Number: NCT02443012

Topical Nepafenac as Supplement for Diabetic Macular Edema

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Topical Gutt Nepafenac 0.1%

Drug

Topical Nepafenac as an adjunct to focal/grid laser

Other names: Nevanac

LASER

Procedure

Grid/Focal Laser Photocoagulation

Primary outcomes

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

    Time frame: 3 months

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

Secondary outcomes

  1. Changes in central macular thickness (measurement of macular thickness)

    Time frame: 3 months

    Measurement of macular thickness using Spectralis OCT

Other outcomes

  1. Safety profile of topical nepafenac as assessed by side effects (such as keratitis, eye redness and blepharitis and epithelial defect)

    Time frame: 3 months

    We look into side effects of topical NSAIDs such as keratitis, eye redness and blepharitis and epithelial defect.

Sponsors and collaborators

Lead sponsor

Universiti Sains Malaysia

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 13, 2015
Registry last updated
May 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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