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

Sponsor

Federal University of São Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT00780780

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema	Drug: Triamcinolone + Nepafenac Drug: triamcinolone intravitreal injection	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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

Actual Study Start Date :

Jul 1, 2007

Actual Primary Completion Date :

Aug 1, 2008

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Nepafenac (Nevanac)
Other: 2 Triamcinolone intravitreal injection	Drug: triamcinolone intravitreal injection triamcinolone intravitreal injection Other Names: triamcinolone

Arm

Intervention/Treatment

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 Names:

Nepafenac (Nevanac)

Other: 2

Triamcinolone intravitreal injection

Drug: triamcinolone intravitreal injection

triamcinolone intravitreal injection

Other Names:

triamcinolone

Outcome Measures

Primary Outcome Measures

Visual acuity [Weeks 1, 4, 8, 12, 20 and 25]
Optical coherence tomography (OCT) [Weeks 4, 8, 12, 20 and 25]

Secondary Outcome Measures

Biomicroscopy/Fundus examination [Day 1, Weeks: 1, 4, 8, 12, 20 and 25]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 years of age at least
Diagnosis of diabetes mellitus (type 1 or type 2. any one of the following will be considered to be sufficient evidence that diabetes is present:
current regular use of insulin for the treatment of diabetes
current regular use of oral hypoglycemic agents for the treatment of diabetes diabetes as defined by american Diabetes Association (ADA)
symptoms of diabetes (polyuria, polydipsia, and unexplained weight loss) or eigth-hour fasting plasma glucose > 126 mg/dl
Diabetic macular edema clinically observable associated with diabetic retinopathy:
prior treated with any treatment or one or three sessions focal laser or grid for DME, intervals between sessions must be at least 30 days
the most recent laser at least 3 months prior to Baseline, or no prior medical therapy for diabetic macular edema, or in the investigator opinion the patient would not benefit from macular laser treatment, or the patient refuses laser treatments
BCVA score between 34 letters (20/320 ETDRS)e 68 letters (20/40 ETDRS) in the study eye measured by the ETDRS method at qualification/baseline visit
Retinal thickness > 250 um by OCT

Exclusion Criteria:

Uncontrolled systemic disease
Initiation of medical therapy for diabetes or a change from oral hypoglycemic agents to insulin therapy within 4 months prior to the qualification visit
Renal failure requiring hemodialysis or peritoneal dialysis within 6 months prior to the qualification visit
Any ocular condition in the study eye that in the opinion of the investigator would prevent a 15 letters improvement of visual acuity (e.g. severe macular ischemia)
Presence of branch retinal vein occlusion, central retinal vein occlusion, uveitis, pseudophakic cystoid edema or any other condition in the study eye which could be contributing to macular edema
Presence of an epiretinal membrane in the study eye
History of IOP elevation in response to steroid treatment in either eye
History of glaucoma or optic nerve head change consistent with glaucoma damage, and/or glaucomatous visual field loss in the study eye
Ocular hypertension in the study eye requiring more than 1 anti-glaucoma medication to maintain IOP < 22mmHg at qualification visit
Presence of anterior chamber intraocular lens in the study eye
Active optic disc or retinal neovascularization in the study eye at qualification visit
Active or history of choroidal neovascularization in the study eye
Presence of rubeosis irides in the study eye at qualification visit
Any active ocular infection (i.e. bacterial, viral, parasitic or fungal) in qualification
History of herpetic infection in the study eye or adnexa
Presence of active or inactive toxoplasmosis in either eye at qualification
Presence of visible scleral thinning or ectasia in the study eye
Media opacity in the study eye at qualification
Intraocular surgery, including cataract surgery, and/or laser of any type in the study eye within 90 days prior to qualification.
History of central serous chorioretinopathy in either eye
History of pars plana vitrectomy in the study eye
History of use of intravitreal steroids in the study eye within 3 months prior qualification
Periocular depot of steroids to the study eye with 3 months prior to qualification
Use of systemic steroids within 1 month prior qualification or anticipated use at any time during the study
Use of inhibitors of carbonic anhydrase within 1 month prior qualification or anticipated use at any time during the study
Use of immunosuppressants, immunomodulators, antimetabolites and/or alkylating agents with 6 months prior to qualification or anticipated use at any time during the study
BCVA < 34 letters (20/200 snellen equivalent) in the non-study eye using the ETDRS at qualification
Known allergy of hypersensitivity to the study medication or its components
Known allergy or contraindication to the use of fluorescein or povidone iodine
Contraindication to pupil dilation in either eye
Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception