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IRCT201205029617N1 IRCT 2012-05-10 Vice-Chancellor in Research Affairs Ahvaz Jundishapur University of Medical Sciences Efficacy of Macular laser Photocoagulation with or without Intravitreal Injection of Bevacizumab (Avastin) or Triamcinolone Acetonide for Diffuse Diabetic Macular Edema Efficacy of Macular laser Photocoagulation with or without Intravitreal Injection of Bevacizumab (Avastin) or Triamcinolone Acetonide for Diffuse Diabetic Macular Edema 2011-05-10 anticipated 105 Complete https://irct.ir/trial/10179 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Diffuse Diabetic Macular Edema. Intervention 1: In group of Laser Photocoagulation alone, we do Macalar Laser Photocoagulation . Intervention 2: In group of Laser Photocoagulation with intravitreal injection of Triamcinolone Acetonide, we do Macular Laser Photocoagulation then 4mg Triamcinolone Acetonde will inject intravitrealy one week later. Intervention 3: In group of Laser Photocoagulation with intravitreal Bevacizumab(Avastin), we do Macular laser photocoagulation then 1.25mg Bevacizumab will inject intravitrealy one week later.
public Dr.Sadeghi.Behnam
Department of Ophthalmology-Emam Hospital-Ahvaz
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 1222 8076 sadeghi.b@ajums.ac.ir Ahvaz Jundishapur Univercity of Medical Scieces scientific Dr.Kasiri.Ali
Department of Ophthalmology-Emam hospital-Ahvaz
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 1222 2670 dr.pazyar@gmail.com Ahvaz Jundishapur University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: patients of either gender aged more than18 years; diabetes mellitus (type 1 or 2); best corrected visual acuity (BCVA) in the study eye between 35 and 69 ETDRS letters at 4 m (Snellen equivalent 1/10-5/10); central foveal thickness more than 270 micrometer; media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus imaging; intraocular pressure (IOP )less than 21 mmHg; ability to return for regular study visits; fellow eye has vissual acuity more than 20/400; fellow eye has received no antivascular endothelial growth factor (VEGF) treatment within the past 3 months and diffuse diabetic macular edema based on fluorescein angiography. Exclusion criteria(ocular criteria were applied to the study eye only): macular ischemia (foveal avascular zone [FAZ] more than1000 micrometer or severe perifoveal intercapillary loss on fluorescein angiography); macular edema due to a cause other than diabetic maculopathy; coexistent ocular disease: a preexisting ocular condition that was likely to preclude vissual acuity improvement despite resolution of macular edema ( foveal atrophy, amblyopia, retinal vascular occlusion, neovascular glaucoma, ...); proliferative diabetic retinopathy more than one disc in area in peripheral retina with or without vitreous hemorrhage and history of intraoccular surgery like as cataract sugery or vitrectomy. 18 years 80 years Both H30-H36 Disorders of choroid and retina Rehabilitation Treatment - Drugs Treatment - Drugs In group of Laser Photocoagulation alone, we do Macalar Laser Photocoagulation . In group of Laser Photocoagulation with intravitreal injection of Triamcinolone Acetonide, we do Macular Laser Photocoagulation then 4mg Triamcinolone Acetonde will inject intravitrealy one week later. In group of Laser Photocoagulation with intravitreal Bevacizumab(Avastin), we do Macular laser photocoagulation then 1.25mg Bevacizumab will inject intravitrealy one week later. Central Macular Thickness. Timepoint: Before and Three months after Treatment. Method of measurement: Central Macular Thickness Evaluate with OCT Instrument. Visual Acuity. Timepoint: Before Treatment and Three Months after Treatment. Method of measurement: Visual Acuity check with snellen chart. Vice-Chancellor in Research Affairs Ahvaz Jundishapur University of Medical Sciences Approved 2011-05-08 Ahvaz Jundishapur University of medical sciences Central Department-Golestan Square Ahvaz Iran (Islamic Republic of)