Lucentis (Ranibizumab) in Diabetic Macular Oedema: a Treatment Evaluation

Inclusion Criteria: * Diagnosis of diabetes mellitus (type 1 or type 2) * Retinal thickening due to diabetic macular oedema involving the centre of the macula and OCT central subfield ≥ 300 microns * Best corrected visual acuity in the study eye between 55 and 79 ETDRS letters at 1 metre (Snellen equivalent ≥ 6/24 and ≤ 6/9) * Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs * Intraocular pressure less than 30 mmHg * Ability to return for study visits * Visual acuity in fellow eye ≥ 2/60 * Fellow eye has received no anti-VEGF treatment within the past 3 months and no expectation of such treatment in next 12 months * No previous laser within 3 months of randomisation * Ability to give informed consent throughout the duration of the study Exclusion Criteria: * Macular ischaemia * Macular oedema from a cause other than diabetic macular oedema * Co-existent ocular disease * Presence of an ocular condition such that visual acuity would not improve from resolution of macular oedema * Presence of an ocular condition that might affect macular oedema or alter visual acuity during the course of the study * A substantial cataract that is likely to be decreasing visual acuity by 3 lines or more * History of treatment for diabetic macular oedema at any time in the past 3 months * History of panretinal scatter photocoagulation (PRP) within 3 months prior to randomisation * Anticipated need for PRP in the 6 months following randomisation. * Proliferative diabetic retinopathy in the study eye. * A condition that, in the opinion of the investigator, would preclude participation in the study. * Haemoglobin A1c \> 11.0 % * A past medical history of significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant * Blood pressure \>170/100 mmHg * Myocardial infarction, other cardiac event requiring hospitalisation, stroke, transient ischaemic attack, or treatment for acute congestive heart failure within 6 months prior to randomisation * Major surgery within 28 days prior to randomisation or major surgery planned during the next 12 months at baseline * Participation in an investigational trial within 30 days of randomisation that involved treatment with any drug that has not received regulatory approval at the time of study entry. Note: subjects cannot receive another investigational drug while participating in the study * Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomisation * Pregnant or lactating women or women intending to become pregnant within the study period including 3 months after study cessation * History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery) within prior 3 months or anticipated within the next 6 months following randomisation. * Aphakia * Uncontrolled glaucoma * External ocular infection, including conjunctivitis, chalazion, or severe blepharitis * Known allergy to fluorescein dye or to any component of the study drug * Fertile male unwilling to use contraception for the duration of the study