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Topical Nepafenac as Supplement for Diabetic Macular Edema

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02443012
Enrollment
47
Registered
2015-05-13
Start date
2013-03-31
Completion date
2014-08-31
Last updated
2015-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema

Keywords

Diabetic Macular Edema, Nepafenac, Laser therapy, Clinically significant macular edema, Adjunct Treatment, Topical Nepafenac

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.

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.

Interventions

DRUGTopical Gutt Nepafenac 0.1%

Topical Nepafenac as an adjunct to focal/grid laser

PROCEDURELaser

Grid/Focal Laser Photocoagulation

Sponsors

Universiti Sains Malaysia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in Logarithm Best Minimal Angle of Resolution Corrected Visual Acuity (LogMAR BCVA) (Measurement of Visual Acuity)3 monthsMeasurement of Best Corrected Visual Acuity by means of refraction using the ETDRS Chart

Secondary

MeasureTime frameDescription
Changes in central macular thickness (measurement of macular thickness)3 monthsMeasurement of macular thickness using Spectralis OCT

Other

MeasureTime frameDescription
Safety profile of topical nepafenac as assessed by side effects (such as keratitis, eye redness and blepharitis and epithelial defect)3 monthsWe look into side effects of topical NSAIDs such as keratitis, eye redness and blepharitis and epithelial defect.

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026