IRCT2017090736088N1 IRCT 2017-09-26 eye research center of isfahan university of medicine comparison of methotrexate vs avastin effect in patient with diabetic macular edema Comparison of combination injection of intravitreal methotrexate and avastin with avastin in diffused diabetic macular edema in diabetic patient in isfahan faiz hospital 2017-2018 2017-09-23 anticipated 44 Complete https://irct.ir/trial/27081 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A diabetic macular edema. in the patients eye that randomized is selected, we injected methotrexate and avastin periodicaly and every 15 days.methotrexate is injected 400 microgram and 0.16ml and after that 0.10cc AC tap.at once the other eye washing and put the measure on conjunctiva. avastin injection is performed on both eyes,1.25mlg in 0.05 in 4mm of limbus..

public behrooz oliya

blind alley22-chaharbaghpaeen-isfahan

isfahan Iran (Islamic Republic of) 8137675631 +98 31 3336 2589 b.oliya@resident.mui.ac.irbehrooz_oliya1th@yahoo.com eye research center of isfahan university of medicine scientific farhad fazel

ophthalmology office-faiz hospital-ghods squre

isfahan Iran (Islamic Republic of) 81496 +98 31 3445 2034 farhadfazel@yahoo.com eye reseach center of isfahan university of medicine Iran (Islamic Republic of) Inclusion criteria: 1- Adult patients (18 years and older) with clinically significant macular edema (CSME) with visual acuity less than 20/50 to Hand motion in the study eye. 2- Optical coherence tomography (OCT) scan demonstrating more than 300 microns central macular edema. 3- Ability to understand study instructions, interventions and potential complications. 4- History of reasonably controlled Diabetes mellitus (DM), ≤ 8.5HbA1c that has been evaluated in the last 3 months. 5-Ability to undergo contraceptive protection during and 3 months after intraocular injections of methtrexate. 6-Clear understanding of teratogenic potential of MTX. Exclusion Criteria: 1- History of allergy to MTX. 2- An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition. 3- An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, epiretinal membrane, etc.). 4- An eye treated for Glaucoma 5- Eyes that underwent vitrectomy 6- History of intraocular malignancies. 7- Intraocular surgery with the prior 3 months. 8-Insulin usage less than a year. 9- Life threatening co morbidities such as cancer under therapy. 10- Use of oral, intravenous, periocular or intraocular corticosteroids (steroids) in prior 3 months. 11-Pregnant females. 12-Vitreous hemorrhage (active) in study eye 13-Media opacities 14-Herpetic disease of cornea 15-Corneal dystrophy with significant corneal edema no limit no limit Both E-10-E-14 h-36 Treatment - Drugs in the patients eye that randomized is selected, we injected methotrexate and avastin periodicaly and every 15 days.methotrexate is injected 400 microgram and 0.16ml and after that 0.10cc AC tap.at once the other eye washing and put the measure on conjunctiva. avastin injection is performed on both eyes,1.25mlg in 0.05 in 4mm of limbus. Visual acuity. Timepoint: at the begining and befor each intervention and one month after the last intervention. Method of measurement: snellen chart in fraction of 10. Central macular thichness. Timepoint: at the begining and befor each intervention and one month after the last intervention. Method of measurement: in micrometer with OCT imaging. Central macular volume. Timepoint: at the begining and befor each intervention and one month after the last intervention. Method of measurement: in microlitre with OCT imaging. Intra ocular pressure. Timepoint: at the begining and befor each intervention and one month after the last intervention. Method of measurement: with goldman tonometer in mmHg. Foveal avascular zone. Timepoint: at begining and one month after the last intervention. Method of measurement: in square millimeter with OCT imaging. Endothelial cell count. Timepoint: at begining and one month after the last intervention. Method of measurement: cells per squre millimeter with specular microscopy. Visual acuity. Timepoint: at the begining of study and after each intervention and one month after last irtervention. Method of measurement: with snellen chart in fraction of 10. Central macular thickness. Timepoint: at the begining of study and after each intervention and one month after last irtervention. Method of measurement: in millimeter in OCT imaging. Central macular volume. Timepoint: at the begining of study and after each intervention and one month after last irtervention. Method of measurement: in millilitre in OCT imaging. Foveal avascular zone. Timepoint: at the begining and after last intervention. Method of measurement: in millimeter in floursein Angiography. Corneal endothelail cell count. Timepoint: at the begining and after last intervention. Method of measurement: in cells per squre millimeter with specular microscopy. Inrtaocular pressure. Timepoint: at the begining of study and after each intervention and one month after last irtervention. Method of measurement: millimeter Hg with goldman tonometer. eye research center of isfahan university of medicine Approved 2016-12-07 eye research center of isfahan university of medical sciences eye research center of isfahan university of medical sciences, Faiz hospital, Ghods square, Isfahan Isfahan Iran (Islamic Republic of)