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

Rubens Belfort Jr.1 site in 1 country142 target enrollmentAugust 2008

Overview

Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema

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

Registry

clinicaltrials.gov

Start Date

August 2008

End Date

December 2013

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Rubens Belfort Jr.

Responsible Party

Sponsor Investigator

Principal Investigator

Rubens Belfort Jr.

Head Professor

Federal University of São Paulo

•18 years of age at least
•Diagnosis of diabetes mellitus (type 1 or type
•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 eighth-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

•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