A single-center, single arm, open label clinical trial to evaluate the efficacy and safety of SRT(Selective Retina Therapy) in patients with Diabetic Macular Edema

The Catholic University of Korea, Yeouido St. Mary's Hospital0 个研究点目标入组 23 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

暂无简介。

•1)Adults older than 19 years
•2)Patients with type II diabetes without a history of ophthalmological treatment
•3)Patients who were diagnosed with clinically significant Diabetic Macular Edema based on the criteria of ETDRS (Early Treatment Diabetic Retinopathy Study)
•4)Patients with decreased visual acuity
•5)Patients with focal edema or patchy diffuse edema
•6)Patients who agreed to participate in this study and signed or whose legally acceptable representative signed the Informed Consent Form

•1)Patients with ischemic Diabetic Macular Edema that showed rupture in the foveal avascular zone due to the obstruction of more than 30% of the capillary vessels in the central circle, as observed using fluorescein fundus angiography
•2)Patients with rubeosis iridis
•3)Patients who cannot be treated with laser due to their cataract or vitreous opacity
•4)Patients with a history of intra-ocular surgery
•5)Patients with a history of focal steroid treatment, injection of anti-VEGF agents, or focal or grid laser exposure of their macular area within 4 months (including Pan retinal photocoagulation)
•6)Patients with glaucoma or other retinal vascular diseases
•7)Patients with confirmed allergy to fluorescein, indocyanine green, or iodine
•8)Patients with clinically significant diseases such as renal failure based on the investigator’s judgment
•9)Patients who are pregnant, breastfeeding, or planning to be pregnant
•10)Patients with other conditions that would make it difficult for them to participate in this study, based on the investigator’s judgment

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