Topical Nepafenac as Supplement for Diabetic Macular Edema

NCT ID: NCT02443012

Last Updated: 2015-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-08-31

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.

Conditions

Diabetic Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Topical Gutt Nepafenac 0.1%

Intervention Type: DRUG

Topical Nepafenac as an adjunct to focal/grid laser

Laser

Intervention Type: PROCEDURE

Grid/Focal Laser Photocoagulation

Laser

Patients with CSME treated with argon laser photocoagulation (focal/grid laser)

Group Type: PLACEBO_COMPARATOR

Laser

Intervention Type: PROCEDURE

Grid/Focal Laser Photocoagulation

Interventions

Topical Gutt Nepafenac 0.1%

Topical Nepafenac as an adjunct to focal/grid laser

Intervention Type: DRUG

Laser

Grid/Focal Laser Photocoagulation

Intervention Type: PROCEDURE

Other Intervention Names

Nevanac

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universiti Sains Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Jan Bond Chan

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zunaina Embong, MS Ophthal

Role: STUDY_CHAIR

Universiti Sains Malaysia

Locations

Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan, Malaysia

Hospital Selayang

Batu Caves, Selangor, Malaysia

Countries

Malaysia

References

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.

Reference Type: BACKGROUND

PMID: 19668417 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18001248 (View on PubMed)

Other Identifiers

1001/PPSP/812064

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NMRR-13-1296-13714

Identifier Type: -

Identifier Source: org_study_id