NCT02443012

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 13, 2015

Completed
Last Updated

May 13, 2015

Status Verified

May 1, 2015

Enrollment Period

1.4 years

First QC Date

April 25, 2015

Last Update Submit

May 8, 2015

Conditions

Diabetic Macular Edema

Keywords

Diabetic Macular EdemaNepafenacLaser therapyClinically significant macular edemaAdjunct TreatmentTopical Nepafenac

Outcome Measures

Primary Outcomes (1)

  • 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

    3 months

Secondary Outcomes (1)

  • Changes in central macular thickness (measurement of macular thickness)

    3 months

Other Outcomes (1)

  • Safety profile of topical nepafenac as assessed by side effects (such as keratitis, eye redness and blepharitis and epithelial defect)

    3 months

Study Arms (2)

Nevanac

EXPERIMENTAL

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%Procedure: Laser

Laser

PLACEBO COMPARATOR

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

Procedure: Laser

Interventions

Topical Gutt Nepafenac 0.1%DRUG

Topical Nepafenac as an adjunct to focal/grid laser

Also known as: Nevanac
Nevanac
LaserPROCEDURE

Grid/Focal Laser Photocoagulation

LaserNevanac

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

Location

Hospital Selayang

Batu Caves, Selangor, 68000, Malaysia

Location

Related Publications (2)

  • 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.

    PMID: 19668417BACKGROUND

  • 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.

    PMID: 18001248BACKGROUND

MeSH Terms

Interventions

nepafenacLasers

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Zunaina Embong, MS Ophthal

    Universiti Sains Malaysia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 25, 2015

First Posted

May 13, 2015

Study Start

March 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

May 13, 2015

Record last verified: 2015-05

Locations

MY(2)