Topical Nepafenac as Supplement for Diabetic Macular Edema

Evaluation on Efficacy of Topical Nepafenac as Supplement Therapy in the Treatment of 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.

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Drug: Topical Gutt Nepafenac 0.1%; Procedure: Laser

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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 4

Contacts and Locations

Study Locations

• Malaysia
  • Kelantan
    • Kubang Kerian, Kelantan, Malaysia, 16150
      • Hospital Universiti Sains Malaysia
  • Selangor
    • Batu Caves, Selangor, Malaysia, 68000
      • Hospital Selayang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Logarithm Best Minimal Angle of Resolution Corrected Visual Acuity (LogMAR BCVA) (Measurement of Visual Acuity)	Measurement of Best Corrected Visual Acuity by means of refraction using the ETDRS Chart	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in central macular thickness (measurement of macular thickness)	Measurement of macular thickness using Spectralis OCT	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety profile of topical nepafenac as assessed by side effects (such as keratitis, eye redness and blepharitis and epithelial defect)	We look into side effects of topical NSAIDs such as keratitis, eye redness and blepharitis and epithelial defect.	3 months

Collaborators and Investigators

• Sponsor: Universiti Sains Malaysia
• Investigators: Study Chair: Zunaina Embong, MS Ophthal, Universiti Sains Malaysia

Publications and helpful links

General Publications

• Callanan D, Williams P. Topical nepafenac in the treatment of diabetic macular edema. Clin Ophthalmol. 2008 Dec;2(4):689-92. doi: 10.2147/opth.s3965.
• Hariprasad SM, Callanan D, Gainey S, He YG, Warren K. Cystoid and diabetic macular edema treated with nepafenac 0.1%. J Ocul Pharmacol Ther. 2007 Dec;23(6):585-90. doi: 10.1089/jop.2007.0062.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ACTUAL): August 1, 2014
• Study Completion (ACTUAL): August 1, 2014

Study Registration Dates

• First Submitted: April 25, 2015
• First Submitted That Met QC Criteria: May 8, 2015
• First Posted (ESTIMATE): May 13, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): May 13, 2015
• Last Update Submitted That Met QC Criteria: May 8, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Diabetic Macular Edema; Nepafenac; Laser therapy; Clinically significant macular edema; Adjunct Treatment; Topical Nepafenac
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Nepafenac
• Other Study ID Numbers: NMRR-13-1296-13714; 1001/PPSP/812064 (OTHER_GRANT: Research University Grant (USM))