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Topical Nepafenac as Supplement for Diabetic Macular Edema

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ClinicalTrials.gov Identifier: NCT02443012
Recruitment Status : Completed
First Posted : May 13, 2015
Last Update Posted : May 13, 2015
Sponsor:
Information provided by (Responsible Party):
Jan Bond Chan, University of Science Malaysia

Brief 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.


Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Topical Gutt Nepafenac 0.1% Procedure: Laser Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Evaluation on Efficacy of Topical Nepafenac as Supplement Therapy in the Treatment of Diabetic Macular Edema
Study Start Date : March 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Nepafenac

Arm Intervention/treatment
Experimental: Nevanac
Patients with CSME treated with argon laser photocoagulation (focal/grid laser) and Topical Gutt Nepafenac 0.1% given 8 hourly interval for 3 months
Drug: Topical Gutt Nepafenac 0.1%
Topical Nepafenac as an adjunct to focal/grid laser
Other Name: Nevanac

Procedure: Laser
Grid/Focal Laser Photocoagulation

Placebo Comparator: Laser
Patients with CSME treated with argon laser photocoagulation (focal/grid laser)
Procedure: Laser
Grid/Focal Laser Photocoagulation




Primary Outcome Measures :
  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 Outcome Measures :
  1. Changes in central macular thickness (measurement of macular thickness) [ Time Frame: 3 months ]
    Measurement of macular thickness using Spectralis OCT


Other Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443012


Locations
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Malaysia
Hospital Universiti Sains Malaysia
Kubang Kerian, Kelantan, Malaysia, 16150
Hospital Selayang
Batu Caves, Selangor, Malaysia, 68000
Sponsors and Collaborators
University of Science Malaysia
Investigators
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Study Chair: Zunaina Embong, MS Ophthal University of Science Malaysia

Publications:
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Responsible Party: Jan Bond Chan, Dr, University of Science Malaysia
ClinicalTrials.gov Identifier: NCT02443012     History of Changes
Other Study ID Numbers: NMRR-13-1296-13714
1001/PPSP/812064 ( Other Grant/Funding Number: Research University Grant (USM) )
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015
Keywords provided by Jan Bond Chan, University of Science Malaysia:
Diabetic Macular Edema
Nepafenac
Laser therapy
Clinically significant macular edema
Adjunct Treatment
Topical Nepafenac
Additional relevant MeSH terms:
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Macular Edema
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Nepafenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents