Efficacy and safety of intravitreal Ziv-aflibercept injection for the treatment of refractory diabetic macula edema

Faculty of Medicine, Khon Kaen University0 个研究点目标入组 7 人开始时间: 2019年11月30日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1. Patients with diabetic macular edema with history of intravitreal Bevacizumab injection at least 3 injections within the past 4 months and are refractory to the treatment
•2. During the last 2 intravitreal Bevacizumab injection, the decrease in central subfield thickness is less than 10% from the baseline
•3. Central subfield thickness is greater than 300 micrometer at the beginning of the study
•4. The glycosylated hemoglobin level in plasma is less than 12%

•1. One-eyed patient
•2. Active Ocular infection (including endophthalmitis, infectious conjunctivitis, blepharitis, etc.)
•3. Ophthalmic conditions which affect the patients' visual acuity or makes fundus photography impossible. (for example, corneal scar, moderate to severe cataract, vitreous haemorrhage, massive retinal haemorrhage)
•4. Patients with history of intravitreal anti-VEGF injection other than Bevacizumab.
•5. Patients with history of intravitreal steroid injection in the past 6 months
•6. Patients with history of vitreoretinal surgery
•7. Patients with history of ophthalmic laser procedure in the past 6 months
•8. Severe hypertension (defined as systolic blood pressure >180 mmHg, or diastolic blood pressure >110 mmHg)
•9. Renal disease requiring renal replacement therapy or kidney transplant
•10. History of ischemic heart disease
•11. History of stroke
•12. Pregnant women, lactating women, or women with intended pregnancy in the next 6 months
•13. Patients who are unable to visit monthly for 6 months

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