Official Title: “A Randomized, Parallel Group, Masked Clinical Study to Evaluate the Efficacy of Triamcinolone and Bevacizumab Through Intravitreal Injection With Individual or Simultaneous Drugs to Treatment of Diabetic Macular Edema”

Efficacy Study of Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

• Drug: Bevacizumab intravitreal
  • Bevacizumab intravitreal 0.05 ml/1.25 mg - administered on D0, Week 4, Week 8
• Drug: Triamcinolone
  • Intravitreal 0.1 ml/4 mg, D0, Week 4 and Week 8
• Drug: Triamcinolone + Bevacizumab
  • Intravitreal triamcinolone 0.1 ml/4 mg + bevacizumab 0.05 ml/1.25 mg simultaneously on D0, week 4, Week 8

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
  • Avastin intravitreal injection D0, Week 4, Week 8
• Active Comparator: B
  • Triamcinolone intravitreal injection
• Active Comparator: C
  • Avastin + Triamcinolone intravitreal injection simultaneously

Primary Measures

• Measurement of visual acuity (E Snellen)
  • Time Frame: monthly
    Safety Issue?: Yes

Secondary Measures

• Tonometry
  • Time Frame: monthly
    Safety Issue?: Yes
• Measurement of retinal thickness by OCT
  • Time Frame: monthly
    Safety Issue?: Yes

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:
• without prior foveal treatment with laser therapy
• if photocoagulation or peripherical or macular laser, at least 3 months
• absence of macular ischemia by fluorescein angiography on baseline visit
• BCVA score between 20 letters (20/400 ETDRS)e 70 letters (20/40 ETDRS) in the study eye measured by the ETDRS method at qualification/baseline visit
• Retinal thickness > 275um by OCT
• One eye per patient will be chosen for the study. In case of both eye eligible, it will be chosen an eye to be treated with study medication and another eye treated with laser
• Taught hyaloid syndrome

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 2 lines 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
• Ocular hypertension requiring more than 1 anti-glaucoma medication to maintain IOP <
• 11mmhg 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Federal University of São Paulo

Overall Clinical Trial Officials and Contacts

Rubens Belfort Jr, MD Principal Investigator Federal University of São Paulo / Dept. of OPhthalmology  

Overall Contact: Rubens Belfort Jr, MD 5511-55726443 clinbelf@uol.com.br

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00737971

Study ID Number: 108/08

ClinicalTrials.gov Identifier: NCT00737971

Health Authority: Brazil: National Committee of Ethics in Research