Overview

Topical Nepafenac as Supplement for Diabetic Macular Edema

Status:
Completed
Trial end date:
2014-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Universiti Sains Malaysia
University of Science Malaysia
Treatments:
Nepafenac
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