NCT00780780

Efficacy Study of Triamcinolone Associated With Nepafenac for Treatment of Diabetic Macular Edema

A Randomized Parallel, Masked to Evaluate the Efficacy of Triamcinolone Associated With Nepafenac (Nevanac) Compared With Intravitreal Injection of Triamcinolone for Treatment of Clinically Significant Diabetic Macular Edema

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Diabetics retinopathy remains the major threat to sight in the working age population in the developed world. Furthermore, it is increasing as a major cause of blindness in other parts of the world, especially developing countries. Diabetic macular edema (DME) is a manifestation of diabetic retinopathy that produces loss of central vision. The triamcinolone intravitreal injection (1-4mg) is indicated to treatment of diabetic macular edema and it is considered an important treatment since it improves the visual acuity of patients with resolution of edema. Nepafenac is a non-steroidal anti-inflammatory drug (NSAID), usually sold as a prescription eye drop (0.1% solution). Nepafenac is manufactured by Alcon as Nevanac. It is approved by FDA as well as ANVISA. Pre-clinical studies suggest this medication showed efficacy to treat ocular posterior segment inflammation. The purpose of this study is evaluate the efficacy of intravitreal triamcinolone associated with nepafenac eye drops as treatment of diabetic macular edema.

Detailed description

We plan to enroll 40 patients in this prospective randomized clinical trial. Eligible patients will be randomized into two groups. All patients will have Early Treatment of Diabetic Retinopathy Study (ETDRS) vision measured and OCT (OCT Stratus - Zeiss)in both eyes in following visits: Baseline, Week 4, 8, 12, 20 and 25. OCT measurements will include total macular volume, central foveal thickness, and average macular thickness. The patients will be evaluated during 25 weeks (7 visits). Parameters for clinical evaluation: visual acuity, IOP, biomicroscopy, fundus examination through dilated pupil and OCT. Group A: 20 patients will receive intravitreal triamcinolone injection Group B: 20 patients will receive intravitreal triamcinolone injection associated with nepafenac eye drops (1 gtt, tid) during 6 months.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Triamcinolone + Nepafenac	Triamcinolone intravitreal injection 0,1 ml (4mg) Nepafenac 1 drop, tid, during 6 months
DRUG	triamcinolone intravitreal injection	triamcinolone intravitreal injection

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-08-01
• Completion: 2012-10-01
• First posted: 2008-10-28
• Last updated: 2018-03-20

Locations

1 site across 1 country: Brazil