IRCT2017090736088N1招募中未知
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
eye research center of isfahan university of medicine0 个研究点目标入组 44 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- no limit 至 no limit（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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
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