Topical Nepafenac as Supplement for Diabetic Macular Edema
Primary Purpose
Diabetic Macular Edema
Status
Completed
Phase
Phase 4
Locations
Malaysia
Study Type
Interventional
Intervention
Topical Gutt Nepafenac 0.1%
Laser
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Diabetic Macular Edema, Nepafenac, Laser therapy, Clinically significant macular edema, Adjunct Treatment, Topical Nepafenac
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
Sites / Locations
- Hospital Universiti Sains Malaysia
- Hospital Selayang
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Nevanac
Laser
Arm Description
Patients with CSME treated with argon laser photocoagulation (focal/grid laser) and Topical Gutt Nepafenac 0.1% given 8 hourly interval for 3 months
Patients with CSME treated with argon laser photocoagulation (focal/grid laser)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Changes in central macular thickness (measurement of macular thickness)
Measurement of macular thickness using Spectralis OCT
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02443012
Brief Title
Topical Nepafenac as Supplement for Diabetic Macular Edema
Official Title
Evaluation on Efficacy of Topical Nepafenac as Supplement Therapy in the Treatment of Diabetic Macular Edema
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Sains Malaysia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
Diabetic Macular Edema, Nepafenac, Laser therapy, Clinically significant macular edema, Adjunct Treatment, Topical Nepafenac
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nevanac
Arm Type
Experimental
Arm Description
Patients with CSME treated with argon laser photocoagulation (focal/grid laser) and Topical Gutt Nepafenac 0.1% given 8 hourly interval for 3 months
Arm Title
Laser
Arm Type
Placebo Comparator
Arm Description
Patients with CSME treated with argon laser photocoagulation (focal/grid laser)
Intervention Type
Drug
Intervention Name(s)
Topical Gutt Nepafenac 0.1%
Other Intervention Name(s)
Nevanac
Intervention Description
Topical Nepafenac as an adjunct to focal/grid laser
Intervention Type
Procedure
Intervention Name(s)
Laser
Intervention Description
Grid/Focal Laser Photocoagulation
Primary Outcome Measure Information:
Title
Changes in Logarithm Best Minimal Angle of Resolution Corrected Visual Acuity (LogMAR BCVA) (Measurement of Visual Acuity)
Description
Measurement of Best Corrected Visual Acuity by means of refraction using the ETDRS Chart
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Changes in central macular thickness (measurement of macular thickness)
Description
Measurement of macular thickness using Spectralis OCT
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Safety profile of topical nepafenac as assessed by side effects (such as keratitis, eye redness and blepharitis and epithelial defect)
Description
We look into side effects of topical NSAIDs such as keratitis, eye redness and blepharitis and epithelial defect.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zunaina Embong, MS Ophthal
Organizational Affiliation
Universiti Sains Malaysia
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universiti Sains Malaysia
City
Kubang Kerian
State/Province
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
Hospital Selayang
City
Batu Caves
State/Province
Selangor
ZIP/Postal Code
68000
Country
Malaysia
12. IPD Sharing Statement
Citations:
PubMed Identifier
19668417
Citation
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.
Results Reference
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PubMed Identifier
18001248
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. doi: 10.1089/jop.2007.0062.
Results Reference
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Topical Nepafenac as Supplement for Diabetic Macular Edema
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