The Influence of Plasma and Aqueous Cytokine Concentrations on the Efficacy of Intravitreal Ranibizumab for the Treatment of Diabetic Macular Oedema.

The Centre for Eye Research Australia (The University of Melbourne)0 个研究点目标入组 30 人开始时间: 2015年8月11日最近更新: 2020年1月13日

试验速览

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•Age >18 years
•-Centre-involving diabetic macular oedema that in the opinion of the investigator, would not benefit from macular laser treatment (eg diffuse leak from the capillary bed, disruption of the foveal avascular zone or perifoveal capillary dropout) as determined by fluorescein angiography
•-Best-corrected visual acuity (BCVA) of 17-70 letters (6/12 –6/120)
•-Central macular thickness of >300 microns as measured by Heidelberg Optical coherence tomography.

•-Uncontrolled blood pressure (>180 mmHg, systolic and 110 mmHg, diastolic)
•-Chronic renal failure
•-Major surgery within one month of study
•-Previous systemic anti-VEGF treatment
•-Women of childbearing potential not using adequate contraception and women who are breast feeding
•-Intercurrent severe disease such as septicaemia
•-Glaucoma which is uncontrolled or is controlled but with glaucomatous visual field defects
•-Past history of severe steroid response with IOP > 35 mmHg following steroid treatment
•-Loss of vision due to other causes (e.g. age-related macular degeneration, myopic macular degeneration)
•-VA of <6/60 in the fellow eye
•-Argon laser photocoagulation within 3 months of study entry
•-Previous intraocular surgery (within 6 months)
•-Prior use of intravitreal anti-VEGF agents (within 3 months) or corticosteroids (within 6 months)
•-Stroke or myocardial infarction less than 3 months prior to screening.
•-Any active periocular or ocular infection or inflammation at screening or baseline.

发起方

The Centre for Eye Research Australia (The University of Melbourne)