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

NCT00780780 | Completed Phase 3

• 1 other identifier: CEP 0754/07
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Macular Edema

Keywords

triamcinolone; nepafenac; DME; edema macular

Outcome Measures

Primary Outcomes (2)

• Visual acuity

  Weeks 1, 4, 8, 12, 20 and 25

• Optical coherence tomography (OCT)

  Weeks 4, 8, 12, 20 and 25

Secondary Outcomes (1)

• Biomicroscopy/Fundus examination

  Day 1, Weeks: 1, 4, 8, 12, 20 and 25

Study Arms (2)

1

ACTIVE COMPARATOR

Triamcinolone intravitreal injection + Nepafenac eye drops

Drug: Triamcinolone + Nepafenac

2

OTHER

Triamcinolone intravitreal injection

Drug: triamcinolone intravitreal injection

Interventions

Triamcinolone + Nepafenac DRUG

Triamcinolone intravitreal injection 0,1 ml (4mg) Nepafenac 1 drop, tid, during 6 months

Also known as: Nepafenac (Nevanac)

1

triamcinolone intravitreal injection DRUG

triamcinolone intravitreal injection

Also known as: triamcinolone

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of Sao Paulo - Dept. of Ophthalmology / Vision Institute

São Paulo, São Paulo, 04023062, Brazil

Location

MeSH Terms

Conditions

Macular Edema

Interventions

Triamcinolone; nepafenac

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Rubens Belfort Jr, MD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 27, 2008
• First Posted: October 28, 2008
• Study Start: July 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: October 1, 2012
• Last Updated: March 20, 2018

Record last verified: 2012-08

Locations

BR (1)