Topical Nepafenac as Supplement for Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02443012
• Other study ID #: NMRR-13-1296-13714
• Secondary ID: 1001/PPSP/812064
• Status: Completed
• Phase: Phase 4
• First received: April 25, 2015
• Last updated: May 8, 2015
• Start date: March 2013
• Est. completion date: August 2014

Study information

• Verified date: May 2015
• Source: University of Science Malaysia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: National Medical Research Register
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Topical Gutt Nepafenac 0.1%
Topical Nepafenac as an adjunct to focal/grid laser

Procedure:
• Laser
Grid/Focal Laser Photocoagulation

Locations

Country	Name	City	State
Malaysia	Hospital Selayang	Batu Caves	Selangor
Malaysia	Hospital Universiti Sains Malaysia	Kubang Kerian	Kelantan

Sponsors (1)

Lead Sponsor	Collaborator
University of Science Malaysia

Country where clinical trial is conducted

Malaysia, 

References & Publications (2)

Callanan D, Williams P. Topical nepafenac in the treatment of diabetic macular edema. Clin Ophthalmol. 2008 Dec;2(4):689-92. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Primary	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	No
Secondary	Changes in central macular thickness (measurement of macular thickness)	Measurement of macular thickness using Spectralis OCT	3 months	No