Evaluation of the efficacy and safety of a Macugen monotherapy versus Combined Therapies in the Treatment of Diabetic Retinopathy – a single centre, randomized, prospective Phase II trial

Johann Wolfgang Goethe-Universität Frankfurt0 个研究点目标入组 120 人开始时间: 2009年3月17日最近更新: 2014年1月27日

适应症

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•age over 18 years of either gender, moderate to severe non proliferative diabetic retinopathy (NPDR) with diabetic cystoid macular edema, informed consent given
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•History of any retinal laser- or kryokoagulation, any intravitreal anti-VEGF, steroid or (core)-vitrectomy within the last 6 months, vitreoretinal traction syndrome, Myopia of >8 diopters, axial length of >26mm, and likelihood of requiring cataract surgery within the ensuing 10 months. Any history of active ocular or periocular infection, radiation to head, neck, or eye; Glycosylated hemoglobin (GHb) levels of >13%; >3 episodes of severe hypoglycemia within 3 months of study entry; >2 episodes of ketoacidosis within 1 year of baseline; or evidence of severe cardiac disease, any disease that makes it impossible to conduct the trial with the patient, pregnancy and lactation, participating in a clinical trial within the last 4 weeks, patients that cannot give informed consent themself, all contra indications for the test drugs

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