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

• ClinicalTrials.gov Identifier: NCT00780780
• Recruitment Status: Completed
• First Posted: October 28, 2008
• Last Update Posted: March 20, 2018
• Sponsor: Federal University of São Paulo
• Information provided by: Federal University of São Paulo

Tracking Information

• First Submitted Date: October 27, 2008
• First Posted Date: October 28, 2008
• Last Update Posted Date: March 20, 2018
• Actual Study Start Date: July 2007
• Actual Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 27, 2008)

• 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 ]

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: October 27, 2008): Biomicroscopy/Fundus examination [ Time Frame: Day 1, Weeks: 1, 4, 8, 12, 20 and 25 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy Study of Triamcinolone Associated With Nepafenac for Treatment of Diabetic Macular Edema
• 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

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.

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 Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment
• Condition: Diabetic Macular Edema

Intervention

• Drug: Triamcinolone + Nepafenac
  Triamcinolone intravitreal injection 0,1 ml (4mg) Nepafenac 1 drop, tid, during 6 months
  Other Name: Nepafenac (Nevanac)
• Drug: triamcinolone intravitreal injection
  triamcinolone intravitreal injection
  Other Name: triamcinolone

Study Arms

• Active Comparator: 1
  Triamcinolone intravitreal injection + Nepafenac eye drops
  Intervention: Drug: Triamcinolone + Nepafenac
• 2
  Triamcinolone intravitreal injection
  Intervention: Drug: triamcinolone intravitreal injection

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 27, 2008): 40
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: October 2012
• Actual Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT00780780
• Other Study ID Numbers: CEP 0754/07
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Rubens Belfort Jr. - Full Professor of Ophthalmology, Federal University of São Paulo
• Original Responsible Party: Same as current
• Current Study Sponsor: Federal University of São Paulo
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Rubens Belfort Jr, MD; Federal University of Sao Paulo

• PRS Account: Federal University of São Paulo
• Verification Date: August 2012