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Topical Nepafenac as Supplement for Diabetic Macular Edema

Information source: University of Science Malaysia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetic Macular Edema

Intervention: Topical Gutt Nepafenac 0.1% (Drug); Laser (Procedure)

Phase: Phase 4

Status: Completed

Sponsored by: University of Science Malaysia

Official(s) and/or principal investigator(s):
Zunaina Embong, MS Ophthal, Study Chair, Affiliation: University of Science Malaysia

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.

Clinical Details

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

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

Primary outcome: Changes in Logarithm Best Minimal Angle of Resolution Corrected Visual Acuity (LogMAR BCVA) (Measurement of Visual Acuity)

Secondary outcome: Changes in central macular thickness (measurement of macular thickness)

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.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Hospital Universiti Sains Malaysia, Kubang Kerian, Kelantan 16150, Malaysia

Hospital Selayang, Batu Caves, Selangor 68000, Malaysia

Additional Information

Related publications:

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

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.

Starting date: March 2013
Last updated: May 8, 2015

Page last updated: August 23, 2015

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