comparison of methotrexate vs avastin effect in patient with diabetic macular edema

Not Applicable

Recruiting

• Conditions: diabetic macular edema.; h-36; E-10-E-14

• Registration Number: IRCT2017090736088N1
• Lead Sponsor: eye research center of isfahan university of medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.