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
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|
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 (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
Grid/Focal Laser Photocoagulation
Placebo Comparator: Laser
Patients with CSME treated with argon laser photocoagulation (focal/grid laser)
Grid/Focal Laser Photocoagulation
- 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
- Changes in central macular thickness (measurement of macular thickness) [ Time Frame: 3 months ]Measurement of macular thickness using Spectralis OCT
- 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.
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
|Hospital Universiti Sains Malaysia|
|Kubang Kerian, Kelantan, Malaysia, 16150|
|Batu Caves, Selangor, Malaysia, 68000|
|Study Chair:||Zunaina Embong, MS Ophthal||University of Science Malaysia|