Prospective, Randomized Clinical Trial Comparing Macular Photocoagulation With or Without Intravitreal Bevacizumab or Triamcinolone for the Treatment of Diabetic Macular Edema

Study Overview
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Brief Summary
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Purpose: To compare the effects of macular photocoagulation with or without intravitreal bevacizumab (IVB) or triamcinolone (IVTA) for the treatment of diabetic macular edema (DME). Casuistic and Methods: 58 eyes of 44 patients with diffuse DME were randomized to receive either IVB + focal/grid laser (IVB-Laser, n=19), IVTA + focal/grid laser (IVTA-Laser, n=16) or focal/grid laser alone (Laser, n=23). Ophthalmic evaluation, including best-corrected visual acuity (BCVA), intraocular pressure (IOP) and central macular thickness (CMT) were performed at baseline and monthly for 12 months.

Official Title
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Bevacizumabe e Acetato de Triancinolona Intra-vítreo Associados à Laserterapia em Pacientes Com Edema Macular diabético (IBeTA)

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Device: Laser
* Drug: Bevacizumab
* Drug: Triamcinolone Acetonide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinically significant diabetic macular edema (DME) with diffuse leakage involving the center of the fovea, with DME greater than 275 microns in OCT examination BCVA between 0.3 LogMAR (logarithm of smaller angle of visual resolution) (20/40) and 1.6 LogMAR (20/800) signed of inform Consent. Exclusion Criteria: HbA1c levels greater than 10% thromboembolic event history (including myocardial infarction and stroke) vitreo-macular traction on OCT coagulation disorders macular ischemia on fluorescein angiography examination proliferative diabetic retinopathy that required treatment eye surgery history of ocular hypertension or glaucoma any ocular pathology which in the opinion of the investigator, could macular edema or change the visual acuity during the study period (for example, retinal vascular occlusion, uveitis or other inflammatory eye disease, neovascular glaucoma) systemic corticosteroid therapy any conditions that could affect the documentation any previous treatment for diabetic macular edema.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IVB-Laser<br>Intravitreal Bevacizumab combined with focal laser therapy | Device: Laser<br>* focal macular laser therapy<br>Drug: Bevacizumab<br>* Intravitreal injection of Bevacizumab<br>|
| Active Comparator: IVTA-Laser<br>Intravitreal Triamcinolone combined with focal laser therapy | Device: Laser<br>* focal macular laser therapy<br>Drug: Triamcinolone Acetonide<br>* Intravitreal injection of Triamcinolone Acetonide<br>|
| Active Comparator: Laser<br>focal laser therapy | Device: Laser<br>* focal macular laser therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central subfield macular thickness | retinal thickness measured with optical coherence tomography | 12 months | 
| Visual acuity | Best corrected visual acuity | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic retinopathy, Macular edema, Anti-VEGF, Triamcinolone