The effect of Ranibizumab (Lucentis) combined with grid laser compared with laser alone on vision in patients with recalcitrant, diabetic macular oedema

ovartis0 个研究点目标入组 40 人开始时间: 2011年1月18日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•I.Age 18 years or older.
•I.Diabetic macula oedema involving the fovea.
•II.OCT central retinal thickness greater than 250 microns or paracentral macular thickness greater than 300um.
•III.Best-corrected visual acuity (BCVA) of 0.3 to 1.90 logMAR (6/12-6/477 Snellen equivalent) in the study eye.
•IV.At least one full grid or 2 focal laser treatments to DMO no sooner than 4 months prior to randomisation.
•V.Adequate renal function (glomerular filtration calculated by Cockcroft/Gault formula or measure urine creatinine clearance > or = to 50 mL/minute

•I.Macular ischaemia on Fundus Fluroscein Angiogram(FFA)
•II.Untreated retinal or iris neovascularization.
•III.Subfoveal fibrosis or atrophy in the study eye.
•IV.History of vitrectomy surgery in the study eye.
•V.History of idiopathic or autoimmune-associated uveitis in either eye.
•VI.Pregnancy, breastfeeding or inadequate birth control in premenopausal females. All patients of child-bearing potential will be required to have a urinary pregnancy test at the screening visit and if sexually active, prior to each intravitreal ranibizumab injection.
•VII.Loss of vision due to other causes,
•VIII.Intercurrent severe systemic disease.
•IX.Any condition affecting follow-up or documentation.
•X.Active ocular, periocular or systemic infection.
•XI.Idiopathic thrombocytopaenic purpura.
•XII.Hypersensitivity to ranibizumab.
•XIII.Previous treatment with anti-vascular endothelial growth factor(VEGF) agents within 6 weeks of enrolment.
•XIV.Triamcinolone intravitreal or subtenon injection within 4 months prior to randomisation.
•XV.Past known history of stroke or myocardial infarction.

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