Study purpose: comparison of combination injection of intravitreal methotrexate and avastin with avastin in diffused diabetic macular edema in diabetic patient, we can use this treatment if it was effective for prevention of disease and improved patient visual acuity in combination with other treatments.
Study Design: clinical trial, single blind and randomized, single center.
Time of study: 2017-2018
Location of study: Iran, Isfahan Faiz hospital
Methods: the 22 patients were selected from the non-treat NPDR patients that come to Isfahan eye clinic Faiz hospital. After selection of patients with inclusion criteria and get informed letter of satisfaction they come to study. the treatment protocol is monthly injection of 1.25 microgram avastin in 0.05 mililitre in one eye and injection of every 15 days, 1.25 microgram avastin in 0.05 mililitre and methotrexate 400 microgram periodical in other eye.in the end of every month, before next injection we get OCT imaging of every eye that exist in Faiz hospital. The visual acuity is taken with snellen chart and in the last comparison with each other. Injections are every month since 3 times. Visual acuity, CMT and CMV is gotten one month after the last injection of avastin.
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
Target sample size: 22 patients (44 eyes).