Efficacy Study of Triamcinolone Associated With Nepafenac for Treatment of Diabetic Macular Edema (NEVANAC)
Recruitment status was: Active, not recruiting
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.
|Diabetic Macular Edema||Drug: Triamcinolone + Nepafenac Drug: triamcinolone intravitreal injection||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- Visual acuity [ Time Frame: Weeks 1, 4, 8, 12, 20 and 25 ]
- Optical coherence tomography (OCT) [ Time Frame: Weeks 4, 8, 12, 20 and 25 ]
- Biomicroscopy/Fundus examination [ Time Frame: Day 1, Weeks: 1, 4, 8, 12, 20 and 25 ]
|Study Start Date:||July 2007|
|Estimated Study Completion Date:||October 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Triamcinolone intravitreal injection + Nepafenac eye drops
Drug: Triamcinolone + Nepafenac
Triamcinolone intravitreal injection 0,1 ml (4mg) Nepafenac 1 drop, tid, during 6 months
Other Name: Nepafenac (Nevanac)
Triamcinolone intravitreal injection
Drug: triamcinolone intravitreal injection
triamcinolone intravitreal injection
Other Name: triamcinolone
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00780780
|Federal University of Sao Paulo - Dept. of Ophthalmology / Vision Institute|
|São Paulo, SP, Brazil, 04023062|
|Principal Investigator:||Rubens Belfort Jr, MD||Federal University of Sao Paulo|