Evaluation of an additional therapeutic approach to diabetic macular edema by combining standard therapy (intravitreal injection of a VEGF-inhibitor) with micropulse diode laser treatment in a randomized, controlled proof of concept study - ReCa

GWT-TUD GmbH0 个研究点开始时间: 2013年12月18日最近更新: 2017年4月3日

适应症

试验速览

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•Patients at least 18 years with DME and 0.05 < BCVA < 0.6 or retinal thickness >300 µm (determined by SD-OCT)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•- Severe ischemic maculopathy of the study eye
•- Active neovascularization of iris or retina in the study eye
•- History of intravitreal injection of VEGF-inhibitor or steroids in study eye within the last 3 month
•- Pathologies of the anterior segment of the study eye with reduced visual acuity (e.g. corneal opacification, advanced cataract)
•- Advanced glaucoma with central defects of the visual field in study eye
•- Retinal pathologies with reduced visual (e.g. central scars, age related macular degeneration) in study eye
•- Retinal vascular occlusion in medical history of study eye
•- Active or suspected ocular or periocular infections
•- Active intraocular inflammation in study eye
•- Intraocular surgery of study eye within the last 6 months
•- Laser therapy of study eye within the last 6 months
•- Systemic steroid therapy within the last 3 month
•- Uncontrolled blood sugar or blood pressure
•- Pregnant or breast feeding woman and woman without adequate method of contraception

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