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

Study Overview
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Brief Summary
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Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema

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

Official Title
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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

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: Bevacizumab intravitreal
* Drug: Triamcinolone
* Drug: Triamcinolone + Bevacizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Avastin intravitreal injection D0, Week 4, Week 8 | Drug: Bevacizumab intravitreal<br>* Bevacizumab intravitreal 0.05 ml/1.25 mg - administered on D0, Week 4, Week 8<br>* Other names: Avastin;|
| Active Comparator: B<br>Triamcinolone intravitreal injection | Drug: Triamcinolone<br>* Intravitreal 0.1 ml/4 mg, D0, Week 4 and Week 8<br>|
| Active Comparator: C<br>Avastin + Triamcinolone intravitreal injection simultaneously | Drug: Triamcinolone + Bevacizumab<br>* Intravitreal triamcinolone 0.1 ml/4 mg + bevacizumab 0.05 ml/1.25 mg simultaneously on D0, week 4, Week 8<br>* Other names: triamcinolone + avastin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of visual acuity (E Snellen) |  | monthly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tonometry |  | monthly | 
| Measurement of retinal thickness by OCT |  | monthly | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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avastin, bevacizumab, triamcinolone, diabetic macular edema, macular edema, intravitreal injection