Diabetic Macular Edema
Conditions
Keywords
avastin, bevacizumab, triamcinolone, diabetic macular edema, macular edema, intravitreal injection
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
Interventions
DRUGBevacizumab intravitreal
Bevacizumab intravitreal 0.05 ml/1.25 mg - administered on D0, Week 4, Week 8
DRUGTriamcinolone
Intravitreal 0.1 ml/4 mg, D0, Week 4 and Week 8
DRUGTriamcinolone + Bevacizumab
Intravitreal triamcinolone 0.1 ml/4 mg + bevacizumab 0.05 ml/1.25 mg simultaneously on D0, week 4, Week 8
Sponsors
Rubens Belfort Jr.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurement of visual acuity (E Snellen) | monthly |
Secondary
| Measure | Time frame |
|---|---|
| Tonometry | monthly |
| Measurement of retinal thickness by OCT | monthly |
Countries
Brazil
Outcome results
None listed