Prospective study evaluating aflibercept in patients with recurrent or prolonged diabetic macular edema after vitrectomy

Kyushu university0 个研究点目标入组 30 人开始时间: 2015年1月1日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Vitrectomized eye with recurrent or prolonged diabetic macular edema more than 6 months after vitrectomy
•( more than 300um in central macular thickness measured by OCT retinal map)
•2) 0.2-1.2 in best-corrected logMAR visual acuity
•3) Type 1 or Type 2 diabetes mellitus
•(20 years and older)
•4) Vitrectomy was performed for not proliferative diabetic retinopathy but for diabetic macular edema
•5) Written informed consent was obtained

•1) Use of any anti VEGF therapy for candidate eyes after vitrectomy
•2) Use of any steroid therapy (except for eye drop) for candidate eyes within 3 months prior to initial injection
•3) Intraocular,periocular inflammation or infection in candidate eye
•4) Allergy history for drug used in this trial
•5) Women who are pregnant or breast feeding or who are capable of becoming pregnant
•6) Focal, grid laser photocoagulation within 3 months prior to initial injection
•7) Proliferative diabetic retinopathy such as vitreous hemorrhage,preretinal hemorrhage,neovascularization, proliferative membrane,tractional retinal detachment
•8) Some of optic disc atrophy
•9) Cataract that would interfere with required fundus examinations, fundus photographs or OCT
•10) Cataract surgery within 6 months prior to initial injection
•11) Systematic diseases( sever heart failure, stroke, blood disease, malignant tumor)
•12) History of systematic steroids treatment
•13) Sever renal failure (serum creatinine>2.0 mg/dL)
•14)Presence of uncontrolled hypertension
•(systolic>180mmHg,diastolic>110mmHg)
•15) HbA1c>10%
•16) Considered unsuitable candidate by clinicians

发起方