Clinical trial NCT00737971: Efficacy Study of Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Macular Edema
Keywords: avastin
bevacizumab
triamcinolone
diabetic macular edema
macular edema
intravitreal injection
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2008-08-20
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema

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

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 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
  * 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

Primary outcomes:
measure: Measurement of visual acuity (E Snellen)
timeFrame: monthly
Secondary outcomes:
measure: Tonometry
timeFrame: monthly
measure: Measurement of retinal thickness by OCT
timeFrame: monthly
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of Sao Paulo - Dept. of Ophthalmology / Vision Institute
Study officials:
affiliation: Federal University of São Paulo / Dept. of OPhthalmology
name: Rubens Belfort Jr, MD
role: PRINCIPAL_INVESTIGATOR
References: